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E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults
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4/3/2019
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4:00 AM
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FDA MedWatch RSS Feed
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The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users.
Full Article
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Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients
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2/25/2019
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5:00 AM
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FDA MedWatch RSS Feed
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FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis
Full Article
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Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients
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12/20/2018
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5:00 AM
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FDA MedWatch RSS Feed
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FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
Full Article
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Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine
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11/20/2018
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5:00 AM
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FDA MedWatch RSS Feed
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FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.
Full Article
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Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration
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11/14/2018
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5:00 AM
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FDA MedWatch RSS Feed
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The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.
Full Article
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SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area
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8/29/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.
Full Article
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Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke
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8/17/2018
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3:00 PM
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FDA MedWatch RSS Feed
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FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.
Full Article
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Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers
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8/8/2018
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6:00 PM
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FDA MedWatch RSS Feed
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The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions.
Full Article
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Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant
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8/3/2018
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2:00 PM
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FDA MedWatch RSS Feed
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The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.
Full Article
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Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products
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7/19/2018
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4:00 AM
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FDA MedWatch RSS Feed
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The investigation into valsartan-containing products is ongoing and there are currently three voluntary recalls related to the NDMA impurity detected in the valsartan
Full Article
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Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects
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7/10/2018
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5:00 PM
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FDA MedWatch RSS Feed
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FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
Full Article
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Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination
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6/22/2018
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3:00 PM
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FDA MedWatch RSS Feed
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The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines
Full Article
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Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks
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6/19/2018
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3:30 PM
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FDA MedWatch RSS Feed
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Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.
Full Article
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Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections
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6/15/2018
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1:00 AM
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FDA MedWatch RSS Feed
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At least 43 patient reported adverse event after receiving eye injections of Guardian?s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields.
FDA identified multiple substances in Guardian?s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared in-house samples of Guardian?s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian?s product (12%, g/100 mL) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration (0.1-0.2%, g/100 mL), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown.
Full Article
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Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter
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6/4/2018
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4:00 AM
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FDA MedWatch RSS Feed
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The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.
Full Article
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Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks
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6/4/2018
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4:00 AM
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FDA MedWatch RSS Feed
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FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.
Full Article
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HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller
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6/1/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death.
Full Article
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STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings: Recall - Patient Port May Detach During Use
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6/1/2018
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4:00 AM
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FDA MedWatch RSS Feed
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The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use.
Full Article
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Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles
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5/31/2018
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6:00 PM
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FDA MedWatch RSS Feed
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The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.
Full Article
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TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules
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5/29/2018
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6:00 PM
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FDA MedWatch RSS Feed
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Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules.
As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous users of the product, increasing the likelihood of taking the capsules out of order. If patients have concerns regarding the possibility of an unintended pregnancy they should consult their physician.
Full Article
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X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination
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5/29/2018
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1:00 PM
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FDA MedWatch RSS Feed
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The products may be contaminated with bacteria. Topical administration of the products could result in potentially serious bacterial infections in immunocompromised individuals.
Full Article
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Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder
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5/23/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Oral over-the-counter benzocaine products should not be used to treat infants and children younger than 2 years and should only be used in adults and children 2 years and older if they contain certain warnings on the drug label.
Full Article
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95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol
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5/23/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Methanol,a highly toxic type of alcohol, can cause serious and sometimes fatal damage if ingested by humans or animals.
Full Article
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HeartMate 3? Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion
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5/22/2018
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2:00 PM
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FDA MedWatch RSS Feed
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The class I recall is due to a malfunction in the device?s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.
Full Article
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Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls
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5/21/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity
Full Article
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Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects
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5/18/2018
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4:00 PM
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FDA MedWatch RSS Feed
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Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects.
Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly. To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. We are investigating this new safety issue and will update the public when we have more information.
Full Article
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Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy
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5/18/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy.
Full Article
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Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter
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5/8/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Piperacillin and Tazobactam for Injection, USP 3.375 g by AuroMedics Pharma: Recall: Exposure to particulate matter may result in local irritation/swelling or more serious outcomes.
Full Article
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Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter
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5/8/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose Vials by AuroMedics Pharma: Recall - Exposure to particulate may result in local site reaction, thromboembolic events and systemic immune response.
Full Article
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Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction
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4/25/2018
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4:00 AM
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FDA MedWatch RSS Feed
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The FDA is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body?s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels. The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system. HLH typically presents as a persistent fever, usually greater than 101?F, and it can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.
Full Article
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Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry
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4/25/2018
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4:00 AM
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FDA MedWatch RSS Feed
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FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment. Posted 04/25/2018
Full Article
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Rhino 69 Extreme 50000 by AMA Wholesale: Recall - Presence of Tadalafil
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4/18/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE5 inhibitors can lead to fatal cardiovascular collapse. Posted 04/18/2018
Full Article
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Euphoric Capsules by Epic Products: Recall - Undeclared Sildenafil and Tadalafil
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4/18/2018
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4:00 AM
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FDA MedWatch RSS Feed
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Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 inhibitors can lead to fatal cardiovascular collapse. Posted 04/18/2018
Full Article
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Certain Implantable Cardiac Devices by Abbott (formerly St. Jude Medical): FDA Safety Communication - Battery Performance Alert and Cybersecurity Firmware Updates
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4/17/2018
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4:00 AM
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FDA MedWatch RSS Feed
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If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. Posted 04/17/2018
Full Article
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Acrodose PLus and PL Systems by Haemonetics: Recall - Low pH Readings for Platelets Stored in CLX HP Bag
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4/13/2018
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1:00 PM
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FDA MedWatch RSS Feed
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Platelets with pH lower than 6.2 and a lack of ?swirl? may not be viable. Transfusion of these platelets may lead to delayed correction of coagulopathy or low quality prophylactic platelet transfusion.
Full Article
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Coastal Meds to Recall All Products Marketed as Sterile
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4/13/2018
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4:00 AM
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FDA MedWatch RSS Feed
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FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection.
Full Article
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Sterile Injectable Products by Premier Pharmacy Labs: Recall - Lack of Sterility Assurance
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4/12/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Administration of non-sterile injection products that are intended to be sterile may result in a site-specific or systemic infection.
Full Article
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System 83 Plus Automated Endoscope Reprocessors (AERs) by Custom Ultrasonics: FDA Safety Communication - Completed Validation Testing
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4/10/2018
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6:50 PM
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FDA MedWatch RSS Feed
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System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope.
Full Article
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Maeng Da Red Powder and Capsules by Club 13: Recall - Possible Contamination With Salmonella
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4/10/2018
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2:50 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution
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4/9/2018
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5:00 PM
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FDA MedWatch RSS Feed
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Sales restricted to only doctors and healthcare facilities who use the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement”.
Full Article
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Kratom-containing Products by Triangle Pharmanaturals: Mandatory Recall - Risk of Salmonella
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4/3/2018
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6:00 PM
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FDA MedWatch RSS Feed
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Salmonella bacteria can cause the foodborne illness salmonellosis. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection.
Full Article
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Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination
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4/3/2018
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2:50 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination
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4/2/2018
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5:40 PM
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FDA MedWatch RSS Feed
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Use of the contaminated product could result in an increased risk of infection.
Full Article
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Eclipse Kratom by Tamarack: Recall - Possible Salmonella Contamination
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3/26/2018
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2:30 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests
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3/23/2018
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3:10 PM
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FDA MedWatch RSS Feed
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Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
Full Article
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NeuroBlate Probe by Monteris Medical: Letter to Health Care Providers, Class I Recall - Unintended Heating
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3/22/2018
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2:15 PM
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FDA MedWatch RSS Feed
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Instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue.
Full Article
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Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton
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3/16/2018
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5:00 PM
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FDA MedWatch RSS Feed
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Consumers may ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their condition or they intend to otherwise avoid, with potential for serious health consequences.
Full Article
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Neurovascular Embolization Coils: Healthcare Provider Letter - Potential for Increased Image Artifact When Using Magnetic Resonance Angiography For Follow-Up
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3/12/2018
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4:15 PM
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FDA MedWatch RSS Feed
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Reduced quality of MRA image from increased artifact can result in inaccurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions.
Full Article
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Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella
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3/12/2018
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3:00 PM
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FDA MedWatch RSS Feed
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Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results
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3/6/2018
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5:00 AM
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FDA MedWatch RSS Feed
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An elevated impurity has the potential to decrease effectiveness of the product in patients. Posted: 03/06/2018
Full Article
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Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials
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3/5/2018
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7:45 PM
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FDA MedWatch RSS Feed
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Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals.
Full Article
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Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance
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3/2/2018
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12:00 PM
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FDA MedWatch RSS Feed
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Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.
Full Article
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Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine
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2/27/2018
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1:00 PM
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FDA MedWatch RSS Feed
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Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke.
Full Article
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Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error Preventing Electrical Shock Delivery
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2/27/2018
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12:00 PM
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FDA MedWatch RSS Feed
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Delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient?s heart whose heartbeat is too slow could result in serious injury and/or death.
Full Article
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Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials
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2/23/2018
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8:00 PM
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FDA MedWatch RSS Feed
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Cracked vials may result in a lack of sterility assurance. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients.
Full Article
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Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease
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2/22/2018
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2:40 PM
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FDA MedWatch RSS Feed
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Prescribers advised to consider using other antibiotics in patients with heart disease.
Full Article
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Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up
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2/13/2018
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10:00 PM
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FDA MedWatch RSS Feed
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Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated.
Full Article
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HeartStart MRx Defibrillator by Philips Electronics: Class I Recall - Defects in Gas Discharge Tubes May Cause Device Failure
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2/9/2018
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4:00 PM
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FDA MedWatch RSS Feed
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Continued use of the device in AED mode after failure may lead to serious patient injury or death.
Full Article
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Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication - Updated Design and Labeling Cleared
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2/7/2018
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4:00 PM
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FDA MedWatch RSS Feed
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Design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap.
Full Article
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Extracorporeal Photopheresis (ECP) Treatment : Letter to Health Care Providers - Death and Pulmonary Embolism
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2/6/2018
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12:00 AM
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FDA MedWatch RSS Feed
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FDA has received seven reports of patients experiencing PE during, or soon after, a treatment.
Full Article
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Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination
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2/2/2018
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1:30 PM
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FDA MedWatch RSS Feed
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Probability of a potentially sight threatening eye infection or impairment.
Full Article
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Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing
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2/1/2018
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2:00 PM
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FDA MedWatch RSS Feed
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FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva.
Full Article
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AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error
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1/31/2018
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1:00 PM
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FDA MedWatch RSS Feed
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Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death.
Full Article
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Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use
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1/30/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Reports of serious heart problems and deaths with much higher than recommended doses of loperamide. FDA working with manufacturers to use blister packs or other single dose packaging and to limit number of doses in a package.
Full Article
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Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination
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1/24/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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"Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination
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1/24/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
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Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved
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1/22/2018
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5:00 AM
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FDA MedWatch RSS Feed
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Misbranded or unapproved new drugs present serious public health risks. Posted 01/22/2018
Full Article
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Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling
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1/22/2018
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5:00 AM
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FDA MedWatch RSS Feed
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Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses. Posted 01/22/2018
Full Article
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Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter
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1/18/2018
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7:00 PM
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FDA MedWatch RSS Feed
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Use of a non-sterile injectable product could result in fatal infections.
Full Article
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Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure
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1/17/2018
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2:40 PM
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FDA MedWatch RSS Feed
|
Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy when needed.
Full Article
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Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions
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1/16/2018
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3:40 PM
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FDA MedWatch RSS Feed
|
Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.
Full Article
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Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced
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1/12/2018
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6:30 PM
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FDA MedWatch RSS Feed
|
eneral use BD syringes are cleared for immediate use in fluid aspiration and injection, but not for use as a closed container storage system for drug products.
Full Article
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Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow
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1/11/2018
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4:30 PM
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FDA MedWatch RSS Feed
|
An embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. Severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.
Full Article
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Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events
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1/11/2018
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2:00 PM
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FDA MedWatch RSS Feed
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Reported pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death.
Full Article
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Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes
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1/11/2018
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1:00 PM
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FDA MedWatch RSS Feed
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Risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.
Full Article
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Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling
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1/11/2018
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12:00 AM
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FDA MedWatch RSS Feed
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Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening.
Full Article
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Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial
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1/4/2018
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1:10 PM
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FDA MedWatch RSS Feed
|
Administration of glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.
Full Article
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Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance
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1/2/2018
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7:30 PM
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FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
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Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub
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1/2/2018
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5:00 PM
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FDA MedWatch RSS Feed
|
Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism).
Full Article
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Linezolid Injection by Auromedics Pharma: Voluntary Recall 600mg/300mL flexible bags- Due to Presence White Particle Matter That Has Been Identified as Mold
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12/26/2017
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5:00 AM
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FDA MedWatch RSS Feed
|
AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold.
Full Article
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Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Related Death Removed
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12/20/2017
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11:00 PM
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FDA MedWatch RSS Feed
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FDA review of clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious asthma-related side effects than treatment with ICS alone.
Full Article
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Pantoprazole Sodium for Injection 40 Mg Per Vial: Recall - Presence of Glass Particles
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12/20/2017
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12:30 PM
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FDA MedWatch RSS Feed
|
Administration of a glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening.
Full Article
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Defibrillation Electrodes for Lifepak AEDs by Physio-Control: Class I Recall - Incorrect Placement Instructions for Infants Depicted on Artwork
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12/19/2017
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8:30 PM
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FDA MedWatch RSS Feed
|
Incorrect placement of electrodes on an infant may result in failure to deliver an effective shock. A delay in therapy could result in serious injury and/or death.
Full Article
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Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings
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12/19/2017
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1:00 PM
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FDA MedWatch RSS Feed
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Trace amounts of gadolinium may stay in the body long-term.
Full Article
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Blue Pearl All Natural Male Enhancement Supplement: Recall - Undeclared Drug Ingredient
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12/14/2017
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1:00 PM
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FDA MedWatch RSS Feed
|
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Full Article
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Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues
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12/5/2017
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3:00 PM
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FDA MedWatch RSS Feed
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The use of impacted alcohol prep pads could result in adverse events such as infections.
Full Article
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Albumin Human 25 Percent Solution (AlbuRx 25): Product Information Advisory - Fading Print On Label
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12/1/2017
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1:30 PM
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FDA MedWatch RSS Feed
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Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label.
Full Article
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Bull Capsules, Chao Jimengnan Tablets by Nutra Labs: Recall - Undeclared Drug Ingredients
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12/1/2017
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1:10 PM
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FDA MedWatch RSS Feed
|
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.
Full Article
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Biotin (Vitamin B7): Safety Communication - May Interfere with Lab Tests
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11/28/2017
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2:00 PM
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FDA MedWatch RSS Feed
|
Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Incorrect test results may lead to inappropriate patient management or misdiagnosis.
Full Article
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Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination
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11/27/2017
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3:10 PM
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FDA MedWatch RSS Feed
|
Use of the affected product potentially could result in a risk of infection, especially in an immunocompromised patient.
Full Article
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Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems
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11/21/2017
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5:00 AM
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FDA MedWatch RSS Feed
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Anyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis. Posted 11/21/2017
Full Article
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Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets
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11/17/2017
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5:00 AM
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FDA MedWatch RSS Feed
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The use of this product in patients with uncontrolled diarrhea due to chronic medical conditions may predispose the patient to toxicity from either the diphenoxylate or atropine components. Posted 11/17/2017
Full Article
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Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter
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11/15/2017
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6:20 PM
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FDA MedWatch RSS Feed
|
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
Full Article
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Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death
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11/15/2017
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4:00 PM
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FDA MedWatch RSS Feed
|
Preliminary safety trial results in over 6,000 patients with gout being evaluated.
Full Article
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Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication - FDA Warns Against Use
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11/14/2017
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3:00 PM
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FDA MedWatch RSS Feed
|
Silicone, when injected into areas with many blood vessels, can travel to other parts of the body and block blood vessels in the lungs, heart, or brain. This can result in permanent damage to those tissues and lead to stroke or death.
Full Article
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Compounded Glutamine, Arginine, and Carnitine Product for Injection by United Pharmacy: Compounding Risk Alert - FDA Investigates Two Adverse Events
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11/8/2017
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8:00 PM
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FDA MedWatch RSS Feed
|
Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences.
Full Article
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Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action - Incorrect Artwork on Packaging
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11/6/2017
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1:30 PM
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FDA MedWatch RSS Feed
|
If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.
Full Article
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Ridge Properties DBA Pain Relief Naturally Products: Recall - Manufacturing Concerns at the Facility
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11/6/2017
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1:00 PM
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FDA MedWatch RSS Feed
|
Risk of decreased quality and consistency (i.e., the safety, identity, strength, quality and purity)
Full Article
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Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market Withdrawal
|
10/23/2017
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|
12:00 PM
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FDA MedWatch RSS Feed
|
Suspend further administration of octagam 10% from production lots K724B8541 and K725A8541.
Full Article
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Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination
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10/21/2017
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4:00 AM
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FDA MedWatch RSS Feed
|
Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections. Posted 10/21/2017
Full Article
|
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Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected
|
10/19/2017
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7:30 PM
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FDA MedWatch RSS Feed
|
UPDATED 10/19/2017. St. Jude Medical notified physicians of the Battery Performance Alert (BPA), a new tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion.
Full Article
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A1 Slim by Kiriko: Recall - Undeclared Drug Ingredients
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10/7/2017
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4:00 AM
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FDA MedWatch RSS Feed
|
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
Full Article
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Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures
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10/6/2017
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3:00 PM
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FDA MedWatch RSS Feed
|
When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.
Full Article
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Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis
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10/3/2017
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7:00 PM
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FDA MedWatch RSS Feed
|
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.
Full Article
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Infant Sleep Positioners: FDA Warning - Risk of Suffocation
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10/3/2017
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2:00 PM
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FDA MedWatch RSS Feed
|
FDA reminding parents and caregivers not to put babies in sleep positioners. These products, sometimes also called ?nests? or ?anti-roll? products, can cause suffocation that can lead to death.
Full Article
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Endovascular Graft Systems: Letter to Health Care Providers - Type III Endoleaks Associated with Use
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9/28/2017
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3:00 PM
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FDA MedWatch RSS Feed
|
Type III endoleak may require treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. Interventions to address endoleaks carry added risks for impacted patients.
Full Article
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Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Clinical Issue
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9/25/2017
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|
10:30 PM
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FDA MedWatch RSS Feed
|
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
Full Article
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TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results
|
9/25/2017
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5:30 PM
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FDA MedWatch RSS Feed
|
UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.
Full Article
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Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient
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9/21/2017
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|
5:00 PM
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FDA MedWatch RSS Feed
|
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.
Full Article
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Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury
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9/21/2017
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2:00 PM
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FDA MedWatch RSS Feed
|
Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label.
Full Article
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Rhino 7, Papa Zen, Fifty Shades, and Grande X Dietary Supplements by Gadget Island: Recall - Undeclared Drug Ingredients
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9/20/2017
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|
9:41 PM
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FDA MedWatch RSS Feed
|
Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may interact with nitrates and may cause a significant drop in blood pressure that may be life threatening.
Full Article
|
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Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks
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9/20/2017
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4:00 PM
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FDA MedWatch RSS Feed
|
Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants.
Full Article
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Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification ? Potential for Counterfeit Raw Material
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9/19/2017
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|
4:00 AM
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FDA MedWatch RSS Feed
|
UPDATED 09/19/2017 Updating after extensive review of data and information.
Full Article
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OriGen VV28F Reinforced Dual Lumen ECMO Catheters: Recall - Potential for Separation of Extension Tube From Hub
|
9/13/2017
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6:00 PM
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FDA MedWatch RSS Feed
|
Separation could result in required intervention to prevent permanent impairment/damage.
Full Article
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Diabetes Infusion Sets by Medtronic: Recall - Vent Membrane May be Susceptible to Being Blocked by Fluid
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9/12/2017
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4:00 AM
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FDA MedWatch RSS Feed
|
May lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Posted 09/12/2017
Full Article
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Baby Organic Liquid Formula by Garden of Life: Recall - Directions For Use May Be Misinterpreted
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9/8/2017
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|
6:00 PM
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FDA MedWatch RSS Feed
|
If not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.
Full Article
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Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance
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9/7/2017
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections.
Full Article
|
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Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump
|
9/6/2017
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|
5:00 PM
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FDA MedWatch RSS Feed
|
If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
Full Article
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Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing
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9/6/2017
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|
1:00 PM
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FDA MedWatch RSS Feed
|
Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal.
Full Article
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Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall - Lack of Sterility Assurance
|
9/5/2017
|
|
7:00 PM
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FDA MedWatch RSS Feed
|
If impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.
Full Article
|
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Unexpired Lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium - Recall - Sub-Potency
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9/1/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient's conditions.
Full Article
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Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues
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9/1/2017
|
|
4:00 AM
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FDA MedWatch RSS Feed
|
The use of these alcohol pads and antiseptic towelettes could cause infections.
Full Article
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Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold
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8/31/2017
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3:00 PM
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FDA MedWatch RSS Feed
|
Risks associated with the use of Keytruda in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.
Full Article
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Vancomycin Hydrochloride for Injection, USP, 750 mg/vial by Hospira: Recall - Presence of Particulate Matter
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8/31/2017
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|
12:00 PM
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FDA MedWatch RSS Feed
|
If administered to a patient, particulate may result in phlebitis, end-organ granuloma or micro-embolic effects, or gastrointestinal trauma.
Full Article
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Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup: Recall - Potential Contamination with Burkholderia cepacia
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8/30/2017
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|
11:00 PM
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FDA MedWatch RSS Feed
|
Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems.
Full Article
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Piyanping Anti-Itch Lotion: Recall - Incorrect Active Ingredient
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8/30/2017
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|
10:00 PM
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FDA MedWatch RSS Feed
|
There is a reasonable probability of the following side effects of topical steroids which include but are not limited to skin changes, adrenal suppression, glaucoma, and cataracts.
Full Article
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Forced Air Thermal Regulating Systems: Healthcare Provider Letter - Information About Use
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8/30/2017
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|
3:00 PM
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FDA MedWatch RSS Feed
|
FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted.
Full Article
|
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Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity Vulnerabilities
|
8/29/2017
|
|
5:00 PM
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FDA MedWatch RSS Feed
|
Vulnerabilities, if exploited, could allow an unauthorized user to access patient's device, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.
Full Article
|
|
Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Recall Correction and Removal of Specific Sizes from Market - Increased Reports of Graft Thrombosis and Occlusion in BTAI Treatment
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8/28/2017
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|
4:00 AM
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FDA MedWatch RSS Feed
|
Correction removed the indication for BTAI; Voluntary recall includes Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device.
Full Article
|
|
Ninjacof and Ninjacof A: Recall - Potential Burkholderia Cepacia Contamination
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8/23/2017
|
|
4:15 PM
|
FDA MedWatch RSS Feed
|
Use of a product that may contain B. cepacia could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Full Article
|
|
Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance
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8/18/2017
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
|
Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall - Potential Formation of Thrombus Inside Device
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8/16/2017
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|
4:00 PM
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FDA MedWatch RSS Feed
|
Thrombus may form inside the device after implantation. Thrombosis or occlusion may lead to serious adverse health consequences, including death.
Full Article
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Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers
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8/16/2017
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|
11:00 AM
|
FDA MedWatch RSS Feed
|
Significant probability of serious health consequences if more than the prescribed dose is dispensed, including: drowsiness causing trauma; increased anxiety; and risk of accidental injury to self or others.
Full Article
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|
Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling
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8/10/2017
|
|
8:00 PM
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FDA MedWatch RSS Feed
|
Common side effects of bupropion include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. Risk of allergic reactions are possible and could be life threatening.
Full Article
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Liquid Products Manufactured by PharmaTech and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories: Recall - Possible Product Contamination
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8/10/2017
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|
7:45 PM
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FDA MedWatch RSS Feed
|
Reports of B. cepacia infections in patients.
Full Article
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Liquid-filled Intragastric Balloon Systems: Letter to Healthcare Providers - Potential Risks
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8/10/2017
|
|
3:00 PM
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FDA MedWatch RSS Feed
|
Five reports of unanticipated deaths that occurred from 2016 to present, in patients with liquid-filled intragastric balloon systems used to treat obesity.
Full Article
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Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance
|
8/10/2017
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
Full Article
|
|
Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use
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8/8/2017
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Advisory due to Burkholderia cepacia contamination and the potential for severe patient infection.
Full Article
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Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead
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8/4/2017
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|
9:25 PM
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FDA MedWatch RSS Feed
|
Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system.
Full Article
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Compounded Curcumin Emulsion Product for Injection by ImprimisRx: FDA Investigation - Serious Adverse Events Associated with Use
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8/4/2017
|
|
3:30 PM
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FDA MedWatch RSS Feed
|
Drug products, including FDA-approved products, containing polyethylene glycol castor oil have been associated with severe and sometimes fatal hypersensitivity reactions.
Full Article
|
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Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination
|
8/3/2017
|
|
5:10 PM
|
FDA MedWatch RSS Feed
|
Use could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Full Article
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Man of Steel 1 and Man of Steel 2: Recall - Undeclared Drug Ingredient
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7/31/2017
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
Use of product found to contained undeclared Sildenafil could result in death. The groups affected include men with diabetes, high blood pressure, high cholesterol, or heart disease.
Full Article
|
|
0.9 Percent Sodium Chloride Injection by ICU Medical: Recall - Presence of Particulate Matter
|
7/31/2017
|
|
4:00 PM
|
FDA MedWatch RSS Feed
|
Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.
Full Article
|
|
Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported
|
7/28/2017
|
|
8:20 PM
|
FDA MedWatch RSS Feed
|
Patients had diminished visual function and adverse reactions after injection into the vitreous of the eye at the end of the cataract surgery procedure.
Full Article
|
|
Cyclobenzaprine HCl and Amantadine HCl by Apace Packaging: Recall - Potential Mislabeling
|
7/28/2017
|
|
2:45 PM
|
FDA MedWatch RSS Feed
|
Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, and other serious adverse events.
Full Article
|
|
Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance
|
7/25/2017
|
|
10:44 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
|
La Bri's Body Health Atomic and Xplode Capsules by EZ Weight Loss TX: Recall - Undeclared Drug Ingredient
|
7/25/2017
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to increase blood pressure and/or pulse rate in some patients and may present a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
Super Panther 7K by Ultra Shop Supplement: Recall - Undeclared Drug Ingredients
|
7/24/2017
|
|
2:30 PM
|
FDA MedWatch RSS Feed
|
Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 can lead to fatal cardiovascular collapse.
Full Article
|
|
Penumbra 3D Revascularization Device by Penumbra: Class I Recall - Wire Material May Break or Separate During Use
|
7/21/2017
|
|
3:25 PM
|
FDA MedWatch RSS Feed
|
Fractured pieces of the delivery wire could be left inside the patient?s brain bloodstream. This or the attempts made to retrieve the fractured pieces can lead to serious adverse health consequences.
Full Article
|
|
ED-530XT Duodenoscopes by Fujifilm: Safety Communication - Recall Issued, Updated Design and Labeling
|
7/21/2017
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Fujifilm issued an Urgent Medical Device Correction and Removal notification, informing customers of its voluntary recall of all ED-530XT duodenoscopes.
Full Article
|
|
Sten Z and M1 Alpha Capsules by Andropharm: Recall - Contains Derivatives of Anabolic Steroids
|
7/12/2017
|
|
6:33 PM
|
FDA MedWatch RSS Feed
|
Consumption of these products may cause elevated blood pressure, aggressive behavior, male infertility, or enlarged breasts and shrinkage of the testes in men.
Full Article
|
|
Novopen Echo Insulin Delivery Device by Novo Nordisk: Recall - May Crack or Break If Exposed To Certain Chemicals
|
7/6/2017
|
|
6:30 PM
|
FDA MedWatch RSS Feed
|
Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar.
Full Article
|
|
Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas
|
7/6/2017
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
UPDATED 07/06/2017. Voluntary recall closed on June 23, 2017. FDA continues to recommend that health care providers discuss with their patients all available treatment options for CEA surgery.
Full Article
|
|
Ultra-Sten and D-Zine Capsules by Hardcore Formulations: Recall - Contains Anabolic Steroids
|
7/6/2017
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Consumption of products containing derivatives of anabolic steroids may cause serious liver injury and other adverse health consequences, including kidney injury, increased risk of heart attack and stroke.
Full Article
|
|
Atar Extension Cables by Oscor: Recall - Cable Separating from Connector
|
7/6/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Posted 07/06/2017
Full Article
|
|
Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services: Recall - Lack of Sterility Assurance
|
6/27/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
Full Article
|
|
ADM Animal Nutrition Recalls Rough-N-Ready Cattle Feed A specific lot of product contains elevated levels of monensin, could harm cattle
|
6/23/2017
|
|
11:31 PM
|
FDA Pet Health RSS Feed
|
ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 50-pound bags of Rough-N-Ready 14 BT cattle feed, product number 54787BHB24, because the product contains elevated levels of monensin beyond the recommended dosage, which could be harmful to cattle. At elevated levels, monensin can be toxic to cattle and can cause colic-like symptoms, hypokalemia, myoglobinuria, chronic cardiovascular issues, and possible death.
Full Article
|
|
Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance
|
6/23/2017
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
Reasonable probability that patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
Full Article
|
|
Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance
|
6/22/2017
|
|
7:20 PM
|
FDA MedWatch RSS Feed
|
Patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
Full Article
|
|
Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use
|
6/21/2017
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
Material in the patient's bloodstream can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.
Full Article
|
|
System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction - Potential Electrical Test Failure Code
|
6/19/2017
|
|
2:15 PM
|
FDA MedWatch RSS Feed
|
Risk of failure of the device to initiate therapy.
Full Article
|
|
Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance
|
6/17/2017
|
|
2:00 AM
|
FDA MedWatch RSS Feed
|
There is a reasonable probability that the patient may experience adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
Full Article
|
|
United Pet Group Expands Voluntary Recall of Multiple Brands of Rawhide Chew Products for Dogs to Also Include Private Label Brands Due to Possible Chemical Contamination
|
6/17/2017
|
|
12:12 AM
|
FDA Pet Health RSS Feed
|
United Pet
Group, a division of Spectrum Brands, Inc. is voluntarily expanding its recall of multiple brands of packages of rawhide dog chew products to include our retail partners? private label brands. The recall involves the brands and products described below.
Full Article
|
|
Frameless Stereotaxic Navigation Systems: FDA Safety Communication - Navigational Accuracy Errors
|
6/15/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Accuracy errors may lead to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures Posted 06/15/2017
Full Article
|
|
Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston: Recall - Sub Potency
|
6/15/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
An extreme and unexpected reduction in dose than expected could lead to a delay in treatment, disruption of clinical care of the patient, and worsening of patient?s conditions. Posted 06/15/2017
Full Article
|
|
Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals: Recall - Dissolution Test Failure
|
6/15/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Failed dissolution could result in less drug being absorbed. Posted 06/15/2017
Full Article
|
|
Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance
|
6/15/2017
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
A patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. Posted 06/16/2017
Full Article
|
|
Loving Pets Voluntarily Recalls Limited Lot Numbers of Air-Puffed Dog Treats Because of Possible Salmonella Health Risk
|
6/14/2017
|
|
9:26 PM
|
FDA Pet Health RSS Feed
|
Loving Pets of Cranbury, NJ is voluntarily recalling a limited number of dog treats because of the potential to be contaminated with Salmonella.
Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the
products or any surfaces exposed to these products.
Full Article
|
|
Topical Products by Phillips Company: Recall - Due to Concerns of Manufacturing Practices
|
6/14/2017
|
|
7:42 PM
|
FDA MedWatch RSS Feed
|
The possibility of decreased quality and consistency of the product, may have an impact on the safety and efficacy of the product posing a risk to patients.
Full Article
|
|
Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets
|
6/13/2017
|
|
6:50 PM
|
FDA MedWatch RSS Feed
|
Patients should not stop taking Eliquis without consulting with their physician
Full Article
|
|
United Pet Group Voluntary Recalls Multiple Brands of Rawhide Chew Products for Dogs Due to Possible Chemical Contamination
|
6/10/2017
|
|
8:41 PM
|
FDA Pet Health RSS Feed
|
United Pet
Group, a division of Spectrum Brands, Inc. is voluntarily recalling multiple brands of packages of rawhide dog chew products that were distributed to retail outlets and sold online in the U.S. The recall involves the brands and products described below.
Full Article
|
|
SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators by Zimmer Biomet: Class I Recall - Potential for Harmful Chemicals
|
5/30/2017
|
|
5:00 PM
|
FDA MedWatch RSS Feed
|
Higher than allowed levels of harmful chemicals may cause chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death. Posted 05/30/2017
Full Article
|
|
Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.: Recall - Out of Sequence Tablets and Missing Expiry/Lot Information
|
5/29/2017
|
|
11:25 PM
|
FDA MedWatch RSS Feed
|
Oral contraceptive tablets that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy.
Full Article
|
|
Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle
|
5/26/2017
|
|
2:39 PM
|
FDA MedWatch RSS Feed
|
Unintentional dosing with Zurampic has the potential to lead to adverse renal effects including acute renal failure.
Full Article
|
|
Caverflo Natural Herbal Coffee: Recall - Presence of Undeclared Active Pharmaceutical Ingredients
|
5/26/2017
|
|
12:19 PM
|
FDA MedWatch RSS Feed
|
Presence of sildenafil and tadalafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
Full Article
|
|
Al-Er-G Capsules by MusclMasster: Recall - Contains Banned Substance Ephedra
|
5/25/2017
|
|
12:20 PM
|
FDA MedWatch RSS Feed
|
Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
Full Article
|
|
HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: Class I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange
|
5/23/2017
|
|
9:06 PM
|
FDA MedWatch RSS Feed
|
A slow or improper driveline changeover places certain patients at risk of serious injury or death.
Full Article
|
|
Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients
|
5/22/2017
|
|
6:50 PM
|
FDA MedWatch RSS Feed
|
Use or consumption of products containing SARMs and anabolic steroid-like substances may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products.
Full Article
|
|
V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down
|
5/22/2017
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
Unexpected stop in ventilation therapy may cause serious adverse health consequences, including death.
Full Article
|
|
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention
|
5/22/2017
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Health care professionals should continue to limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs.
Full Article
|
|
LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results
|
5/17/2017
|
|
1:20 PM
|
FDA MedWatch RSS Feed
|
Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
Full Article
|
|
Coronary Catheters by Abbott: Recall - Difficulty in Removing Balloon Sheath
|
5/16/2017
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction.
Full Article
|
|
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations
|
5/16/2017
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
New warnings, including a Boxed Warning, to be added to the canagliflozin drug labels.
Full Article
|
|
Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength
|
5/8/2017
|
|
7:30 PM
|
FDA MedWatch RSS Feed
|
UPDATED 5/8/2017. C.O. Truxton expands their 04/21/2017 recall to include additional products.
Full Article
|
|
C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Amitriptyline HCL Tablets, USP 50mg and Phenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg Due to Potential Label Mix-Up
|
5/8/2017
|
|
7:15 PM
|
FDA Pet Health RSS Feed
|
Bellmawr, New Jersey, C.O. Truxton, Inc. is expanding their 04/21/2017 voluntary recall, as a precaution to include the following C.O. Truxton, Inc. products, registered NDC numbers and corresponding lot numbers, to the consumer/user level. C.O. Truxton has not received any complaints for the products listed below. however, due to the initial recall resulting from a label mix-up error, out of an abundance of caution, we are recalling all products that were repackaged into a Truxton Incorporated label.
Full Article
|
|
GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall - Presence of Anabolic Steroids
|
5/8/2017
|
|
12:15 PM
|
FDA MedWatch RSS Feed
|
Use or consumption of products containing anabolic steroids may cause acute liver injury. Abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children.
Full Article
|
|
HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device by Medtronic: Recall - May Cause Electrical Issues or Pump Stops
|
5/5/2017
|
|
6:10 PM
|
FDA MedWatch RSS Feed
|
An interruption in electrical connection may cause the pump to stop, which may lead to serious adverse health consequences, including death.
Full Article
|
|
Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software
|
5/4/2017
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
Loose connector may allow moisture to enter controller causing corrosion, electrical issues, reduced speaker volume and connection failures which could cause serious adverse health consequences, including death.
Full Article
|
|
Wingman35 Crossing Catheters by ReFlow Medical: Recall - Tip Splitting or Separation
|
5/3/2017
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.
Full Article
|
|
NavLock Tracker by Medtronic: Letter to Healthcare Providers - Patient Injuries Reported
|
5/3/2017
|
|
1:55 PM
|
FDA MedWatch RSS Feed
|
Minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic's NavLock Tracker.
Full Article
|
|
Newport HT70 and HT70 Plus Ventilators by Medtronic: Field Corrective Action - Ventilator May Reset Spontaneously
|
5/2/2017
|
|
7:01 PM
|
FDA MedWatch RSS Feed
|
UPDATED 05/02/2017. Class I Recall. Potential for ventilator reset during normal operation, without an accompanying alarm.
Full Article
|
|
General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children
|
4/27/2017
|
|
5:15 PM
|
FDA MedWatch RSS Feed
|
Exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.
Full Article
|
|
Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure
|
4/25/2017
|
|
1:25 PM
|
FDA MedWatch RSS Feed
|
Use of unproven or unapproved products may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment.
Full Article
|
|
Party Animal Recalls Dog Food Due To Potential Presence of Pentobarbital
|
4/25/2017
|
|
12:01 AM
|
FDA Pet Health RSS Feed
|
On April 13, a retailer in Texas notified us that
their customer had presented samples of our 13-ounce-can Cocolicious Beef & Turkey
dog food (Lot #0136E15204 04, best by July 2019) and 13-ounce-can Cocolicious
Chicken & Beef dog food (Lot #0134E15 237 13, best by August 2019) to a testing lab,
and that the results had tested positive for pentobarbital.
Full Article
|
|
25 Percent Dextrose Injection, USP (Infant) by Hospira: Recall - Particulate Matter
|
4/24/2017
|
|
2:05 PM
|
FDA MedWatch RSS Feed
|
Particulate administered to a patient could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response to the particulate.
Full Article
|
|
C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Phenobarbital 15 mg Tablets, USP due to Labeling Error on Declared Strength
|
4/21/2017
|
|
4:52 PM
|
FDA Pet Health RSS Feed
|
Bellmawr, New Jersey, C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15 mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15 mg was found to contain phenobarbital 30 mg tablets.
Full Article
|
|
Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women
|
4/20/2017
|
|
3:30 PM
|
FDA MedWatch RSS Feed
|
New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death.
Full Article
|
|
Organic Herbal Supply Supplement Products: Recall - Undeclared Drug Ingredients
|
4/19/2017
|
|
12:55 PM
|
FDA MedWatch RSS Feed
|
Use of these products may pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.
Full Article
|
|
StrataMR Adjustable Valves and Shunts by Medtronic: Recall - Potential for Under-Drainage of Cerebrospinal Fluid
|
4/9/2017
|
|
1:29 AM
|
FDA MedWatch RSS Feed
|
If left untreated, under-drainage can potentially lead to coma and death.
Full Article
|
|
Sterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility Assurance
|
4/6/2017
|
|
8:35 PM
|
FDA MedWatch RSS Feed
|
Voluntary recall of all lots of sterile products, to the hospital/user level.
Full Article
|
|
EpiPen and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device
|
3/31/2017
|
|
11:00 PM
|
FDA MedWatch RSS Feed
|
Failure to activate or increased force needed to activate may have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).
Full Article
|
|
Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use
|
3/31/2017
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
Tip could enter the patient's bloodstream, resulting in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.
Full Article
|
|
LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient
|
3/30/2017
|
|
1:50 PM
|
FDA MedWatch RSS Feed
|
Sibutramine may substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
|
3/21/2017
|
|
5:00 PM
|
FDA MedWatch RSS Feed
|
BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.
Full Article
|
|
EuroCan Manufacturing Voluntarily Recalling Barnsdale Farms? Pig Ears Because of Possible Salmonella Health Risk
|
3/20/2017
|
|
10:47 PM
|
FDA Pet Health RSS Feed
|
(March 20, 2017) New Hamburg, Ontario - EuroCan Manufacturing is voluntarily recalling Lot
Number 84 consisting of it's individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags of
Barnsdale Farms?, HoundsTooth? and Mac's Choice? Pig Ears because they have the potential to be
contaminated with Salmonella. Salmonella can affect animals eating the products and there is a risk to
humans from handling contaminated pet products, especially if they have not thoroughly washed their
hands after having contact with the products or any surfaces exposed to these products.
Full Article
|
|
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events
|
3/18/2017
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent.
Full Article
|
|
Blue Buffalo Voluntarily Recalls One Lot of BLUE Wilderness? Rocky Mountain Recipe TM Red Meat Dinner Wet Food For Adult DogsDue to Potential Health Risk
|
3/18/2017
|
|
2:27 AM
|
FDA Pet Health RSS Feed
|
Blue Buffalo Company is voluntarily recalling one production lot of BLUE Wilderness? Rocky Mountain RecipeTM Red Meat Dinner Wet Food for Adult Dogs, as the product has the potential to contain elevated levels of naturally- occurring beef thyroid hormones.
Full Article
|
|
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
|
3/18/2017
|
|
1:19 AM
|
FDA Pet Health RSS Feed
|
WellPet has initiated a voluntary recall of a limited amount of one canned topper product due to potential elevated levels of naturally occurring beef thyroid hormone.
Full Article
|
|
Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs Due to Potential Elevated Levels of Naturally Occurring Beef Thyroid Hormone
|
3/18/2017
|
|
1:19 AM
|
FDA Pet Health RSS Feed
|
WellPet has initiated a voluntary recall of a limited amount of one canned topper product due to potential elevated levels of naturally occurring beef thyroid hormone.
Full Article
|
|
Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder
|
3/15/2017
|
|
4:02 PM
|
FDA MedWatch RSS Feed
|
Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.
Full Article
|
|
Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder
|
3/15/2017
|
|
4:02 PM
|
FDA MedWatch RSS Feed
|
Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.
Full Article
|
|
SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus
|
3/14/2017
|
|
5:20 PM
|
FDA MedWatch RSS Feed
|
Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
Full Article
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SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus
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3/14/2017
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5:20 PM
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FDA MedWatch RSS Feed
|
Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
Full Article
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Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery
|
3/9/2017
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7:23 PM
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FDA MedWatch RSS Feed
|
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Full Article
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Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices
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3/9/2017
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6:40 PM
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FDA MedWatch RSS Feed
|
Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.
Full Article
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Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices
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3/9/2017
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6:40 PM
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FDA MedWatch RSS Feed
|
Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.
Full Article
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SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination
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3/9/2017
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4:00 PM
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FDA MedWatch RSS Feed
|
Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.
Full Article
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SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination
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3/9/2017
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4:00 PM
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FDA MedWatch RSS Feed
|
Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.
Full Article
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Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures
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3/8/2017
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6:30 PM
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FDA MedWatch RSS Feed
|
Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials
Full Article
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Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures
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3/8/2017
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6:30 PM
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FDA MedWatch RSS Feed
|
Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials
Full Article
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Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient
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3/8/2017
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1:00 AM
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FDA MedWatch RSS Feed
|
PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
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Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient
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3/8/2017
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1:00 AM
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FDA MedWatch RSS Feed
|
PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
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Evanger?s Pet Food and Against the Grain Voluntarily Recalls Additional Products Out of Abundance of Caution due to Potential Adulteration with Pentobarbital
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3/4/2017
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4:04 PM
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FDA Pet Health RSS Feed
|
Out of an abundance of caution, Evanger's Dog & Cat Food is voluntarily expanding its recall of Hunk of Beef and is also recalling Evanger's Braised Beef and Against the Grain?s Pulled Beef Products due to potential adulteration with pentobarbital.?Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.
Full Article
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Evanger?s Pet Food and Against the Grain Voluntarily Recalls Additional Products Out of Abundance of Caution due to Potential Adulteration with Pentobarbital
|
3/4/2017
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|
4:04 PM
|
FDA Pet Health RSS Feed
|
Out of an abundance of caution, Evanger's Dog & Cat Food is voluntarily expanding its recall of Hunk of Beef and is also recalling Evanger's Braised Beef and Against the Grain?s Pulled Beef Products due to potential adulteration with pentobarbital.?Oral exposure to pentobarbital can cause drowsiness, dizziness, excitement, loss of balance, nausea, nystagmus (eyes moving back and forth in a jerky manner), inability to stand, coma and death. Consumers who notice these symptoms in their pets should consult their veterinarian.
Full Article
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Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance
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2/27/2017
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6:00 PM
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FDA MedWatch RSS Feed
|
Loss of container closure integrity could impact the product?s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically.
Full Article
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Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance
|
2/27/2017
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|
6:00 PM
|
FDA MedWatch RSS Feed
|
Loss of container closure integrity could impact the product’s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically.
Full Article
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Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex
|
2/25/2017
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|
1:00 AM
|
FDA MedWatch RSS Feed
|
Risk of potential adverse events can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex.
Full Article
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Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled ?Latex Free?: Recall - Products May Contain Synthetic or Natural Latex
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2/25/2017
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|
1:00 AM
|
FDA MedWatch RSS Feed
|
Risk of potential adverse events can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex.
Full Article
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XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient
|
2/22/2017
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|
1:00 PM
|
FDA MedWatch RSS Feed
|
Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Full Article
|
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XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient
|
2/22/2017
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|
1:00 PM
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FDA MedWatch RSS Feed
|
Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Full Article
|
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Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate
|
2/16/2017
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2:30 PM
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FDA MedWatch RSS Feed
|
Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Full Article
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Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate
|
2/16/2017
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|
2:30 PM
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FDA MedWatch RSS Feed
|
Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Full Article
|
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HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance
|
2/15/2017
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|
1:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
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HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance
|
2/15/2017
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|
1:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
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Against The Grain Pet Food Voluntarily Recalls One Lot of Pulled Beef Due to Potential Adulteration with Pentobarbital
|
2/15/2017
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|
12:33 AM
|
FDA Pet Health RSS Feed
|
Out of an abundance of caution, Against the Grain Pet Food is voluntarily recalling one lot of Against the Grain Pulled Beef with Gravy Dinner for Dogs that was manufactured and distributed in 2015. The 12 oz. Against the Grain Pulled Beef with Gravy Dinner for Dogs that is being voluntarily recalled, due to the potential presence of pentobarbital, has an expiration date of December 2019, a lot number of 2415E01ATB12, and the second half of the UPC code is 80001 (which can be found on the back of the product label).
Full Article
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PetSmart Voluntarily Recalls Single Lot of Grreat Choice? Canned Dog Food Due to Possible Health Risk
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2/10/2017
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|
7:56 PM
|
FDA Pet Health RSS Feed
|
PetSmart has issued a voluntary recall of one production lot of its Grreat Choice? Adult Dog Food sold on PetSmart.com, Pet360.com, PetFoodDirect.com and in nationwide PetSmart retail stores. This product is being voluntarily recalled as a precautionary measure due to metal contamination that could potentially be a choking hazard to pets.
Full Article
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Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error
|
2/9/2017
|
|
4:00 PM
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FDA MedWatch RSS Feed
|
Faulty Air-In-Line sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. Interruption of infusion could lead to serious adverse health consequences or death.
Full Article
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Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error
|
2/9/2017
|
|
4:00 PM
|
FDA MedWatch RSS Feed
|
Faulty Air-In-Line sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. Interruption of infusion could lead to serious adverse health consequences or death.
Full Article
|
|
Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter
|
2/9/2017
|
|
2:35 PM
|
FDA MedWatch RSS Feed
|
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.
Full Article
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Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter
|
2/9/2017
|
|
2:35 PM
|
FDA MedWatch RSS Feed
|
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening.
Full Article
|
|
Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids
|
2/9/2017
|
|
12:45 PM
|
FDA MedWatch RSS Feed
|
Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
Full Article
|
|
Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids
|
2/9/2017
|
|
12:45 PM
|
FDA MedWatch RSS Feed
|
Supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death.
Full Article
|
|
Evanger?s Voluntarily Recalls Hunk of Beef Because Of Pentobarbital Exposure in one Batch of Food
|
2/3/2017
|
|
10:05 PM
|
FDA Pet Health RSS Feed
|
Out of an abundance of caution, Evanger?s Dog & Cat Food of Wheeling, IL is voluntarily recalling specific lots of its Hunk of Beef product because of a potential contaminant Pentobarbital, which was detected in one lot of Hunk of Beef Au Jus. Pentobarbital can affect animals that ingest it, and possibly cause side effects such as drowsiness, dizziness, excitement, loss of balance, or nausea, or in extreme cases, possibly death.
Full Article
|
|
Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions
|
2/2/2017
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|
6:24 PM
|
FDA MedWatch RSS Feed
|
Reactions can occur within minutes of exposure, and may include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, a life-threatening condition.
Full Article
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Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions
|
2/2/2017
|
|
6:24 PM
|
FDA MedWatch RSS Feed
|
Reactions can occur within minutes of exposure, and may include wheezing or difficulty breathing; swelling of the face; hives that can quickly progress to more serious symptoms; severe rash; or shock, a life-threatening condition.
Full Article
|
|
Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage
|
1/30/2017
|
|
7:10 PM
|
FDA MedWatch RSS Feed
|
The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
Full Article
|
|
Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage
|
1/30/2017
|
|
7:10 PM
|
FDA MedWatch RSS Feed
|
The affected product may cause serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
Full Article
|
|
Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna
|
1/27/2017
|
|
6:55 PM
|
FDA MedWatch RSS Feed
|
Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Posted 01/27/2017
Full Article
|
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Certain Homeopathic Teething Products: FDA Warning- Confirmed Elevated Levels of Belladonna
|
1/27/2017
|
|
6:55 PM
|
FDA MedWatch RSS Feed
|
Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Posted 01/27/2017
Full Article
|
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NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall - Potential Inaccurate Test Results
|
1/27/2017
|
|
6:15 PM
|
FDA MedWatch RSS Feed
|
Risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment.
Full Article
|
|
NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall - Potential Inaccurate Test Results
|
1/27/2017
|
|
6:15 PM
|
FDA MedWatch RSS Feed
|
Risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment.
Full Article
|
|
Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial
|
1/25/2017
|
|
1:00 PM
|
FDA MedWatch RSS Feed
|
Injected particulate may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.
Full Article
|
|
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions
|
1/17/2017
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Updated recommendations to help prevent the spread of infection associated with the use of these devices.
Full Article
|
|
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery
|
1/14/2017
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
Full Article
|
|
Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use
|
1/13/2017
|
|
4:00 PM
|
FDA MedWatch RSS Feed
|
Fuji removing legacy 250/450 duodenoscope models from clinical use, replacing with with the ED-530XT model.
Full Article
|
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PNC-27 Products: FDA Warning ? Do Not Use For Treatment or Cure for Cancer
|
1/12/2017
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|
2:00 PM
|
FDA MedWatch RSS Feed
|
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections.
Full Article
|
|
Medrad Intego PET Infusion System Source Administration Sets by Bayer: Corrective Action - Particulates Generated in Vial
|
1/11/2017
|
|
10:30 PM
|
FDA MedWatch RSS Feed
|
The particulate matter could enter into the patient and cause serious adverse health consequences including infection, damage of tissue, and death.
Full Article
|
|
Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions
|
1/11/2017
|
|
3:50 PM
|
FDA MedWatch RSS Feed
|
Reports of serious adverse events, including patient injury & death, describing medication dosing inaccuracies and other mechanical problems with pumps after an MRI exam.
Full Article
|
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Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified
|
1/9/2017
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
These vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient's RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.
Full Article
|
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ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions
|
12/23/2016
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|
2:35 PM
|
FDA MedWatch RSS Feed
|
IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing. Do not rely on presumptive positive Zika virus IgM test results as the sole basis of significant patient management decisions.
Full Article
|
|
Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization
|
12/20/2016
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death.
Full Article
|
|
Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised
|
12/16/2016
|
|
5:01 PM
|
FDA MedWatch RSS Feed
|
FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected.
Full Article
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|
Ridley Block Operations Announces Voluntary Recall of Ultralyx 24% + 3% Mag Composite
|
12/15/2016
|
|
3:24 PM
|
FDA Pet Health RSS Feed
|
Ridley Block Operations has initiated a voluntary recall of a single batch of its beef cattle feed product, Ultralyx 24% + 3% Mag Composite Block, because it contains elevated levels of non-protein nitrogen (NPN) that may be harmful to beef cattle.
Full Article
|
|
General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women
|
12/14/2016
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|
5:01 PM
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FDA MedWatch RSS Feed
|
Published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain.
Full Article
|
|
Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer
|
12/12/2016
|
|
8:05 PM
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FDA MedWatch RSS Feed
|
FDA approved label updates to describe additional studies reviewed.
Full Article
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Convenience Kits containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate
|
12/9/2016
|
|
8:30 PM
|
FDA MedWatch RSS Feed
|
Excess material may separate from catheter during use and enter patient’s bloodstream, resulting in serious adverse health consequences such as blood clots, embolism of the excess material to vital organs, or death.
Full Article
|
|
Blue Ridge Beef of Eatonton, GA Recalls Product Because of Possible Health Risk
|
12/9/2016
|
|
8:05 PM
|
FDA Pet Health RSS Feed
|
Blue Ridge Beef is voluntarily recalling two (2) of its frozen products due to their potential to be contaminated with salmonella and/or listeria monocytogenes. Salmonella and Listeria can affect animals eating the product. There is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surface exposed to these products.
Full Article
|
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Intermountain Farmers Association Issues Recall of Rabbit Feed for High Vitamin D Content
|
12/1/2016
|
|
7:39 PM
|
FDA Pet Health RSS Feed
|
Intermountain Farmers Association (IFA) of Draper, UT, is recalling its 50 lbs. bags of rabbit pellets (item #1220) manufactured between March 14, 2016 and September 15, 2016, because the product may contain higher than acceptable levels of vitamin D, which may cause health problems to rabbits.
Full Article
|
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Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients
|
12/1/2016
|
|
1:40 PM
|
FDA MedWatch RSS Feed
|
Undeclared tadalafil and sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Full Article
|
|
Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient
|
12/1/2016
|
|
1:15 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Full Article
|
|
DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk
|
11/26/2016
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Full Article
|
|
Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids
|
11/25/2016
|
|
5:00 AM
|
FDA MedWatch RSS Feed
|
The homeopathic products have a very small amount of belladonna, a substance that can cause harm at larger doses.
Full Article
|
|
FindrWIRZ Guidewire System by SentreHeart: Class I Recall - Coating Separation
|
11/22/2016
|
|
7:50 PM
|
FDA MedWatch RSS Feed
|
Can lead to serious adverse health consequences including embolism, stroke, or death.
Full Article
|
|
Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance
|
11/21/2016
|
|
8:00 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening.
Full Article
|
|
Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance
|
11/21/2016
|
|
5:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Full Article
|
|
GNC Women?s Ultra Mega Time Release 180 count Dietary Supplement by Nutra Manufacturing: Recall - Undeclared Milk
|
11/18/2016
|
|
7:00 PM
|
FDA MedWatch RSS Feed
|
People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction.
Full Article
|
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Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes
|
11/15/2016
|
|
5:10 PM
|
FDA MedWatch RSS Feed
|
Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist.
Full Article
|
|
Skinny Bee Diet by Love My Tru Body: Recall - Undeclared Drug Ingredients
|
11/8/2016
|
|
8:50 PM
|
FDA MedWatch RSS Feed
|
Undeclared sibutramine, desmethylsibutramine, and/phenolphthalein present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Full Article
|
|
Side Head Regulator TT Tablet by Life Rising/Ton Shen Health: Recall - Elevated Levels of Lead
|
11/8/2016
|
|
2:15 PM
|
FDA MedWatch RSS Feed
|
Acute lead poisoning may cause abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Long term exposure can lead to permanent damage to the central nervous system. Posted 11/08/2016
Full Article
|
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HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Loose Connectors May Prevent Alarm from Sounding
|
10/28/2016
|
|
6:45 PM
|
FDA MedWatch RSS Feed
|
Loose power connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures.
Full Article
|
|
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results
|
10/26/2016
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
The most recent post-approval study results assessing post-market performance is available.
Full Article
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Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence
|
10/25/2016
|
|
4:29 PM
|
FDA MedWatch RSS Feed
|
New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.
Full Article
|
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HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues
|
10/24/2016
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
Full Article
|
|
Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use
|
10/20/2016
|
|
6:00 PM
|
FDA MedWatch RSS Feed
|
Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.
Full Article
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Radiation Therapy Devices by Multidata Systems International: Discontinue Use ? Concerns about Risks to Patients
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10/20/2016
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1:30 PM
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FDA MedWatch RSS Feed
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The FDA is concerned that health care providers may be unaware of the risks associated with these devices.
Full Article
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Medtronic Neurovascular Products: Recall - Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating
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10/18/2016
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4:01 PM
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FDA MedWatch RSS Feed
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PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.
Full Article
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Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue
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10/14/2016
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6:30 PM
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FDA MedWatch RSS Feed
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User may not be able to connect electrodes to Welch Allyn AED model 10 defibrillator, which may result in a delay in delivering the electrical therapy.
Full Article
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St?ckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication - Reports of Mycobacterium Chimaera Infections
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10/13/2016
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7:00 PM
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FDA MedWatch RSS Feed
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New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.
Full Article
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Mars Petcare US Announces Voluntary Recall of Limited Number of CESAR® Classics Filet Mignon Flavor Wet Dog Food Because of Potential Presence of Plastic
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10/11/2016
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2:44 PM
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FDA Pet Health RSS Feed
|
Today, Mars Petcare US of Franklin, Tennessee, announced a voluntary recall of a limited number of CESAR Classics Filet Mignon Flavor product due to a potential choking risk from hard white pieces of plastic which entered the food during the production process. CESAR Classics Filet Mignon can be purchased individually, as well as, in flavor variety multipacks.
Full Article
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Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected
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10/11/2016
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2:20 PM
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FDA MedWatch RSS Feed
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In some cases full battery drainage can occur within a day to a few weeks after patient receives ERI alert. If battery runs out, ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.
Full Article
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I.V. Flush Syringes by Nurse Assist: Recall - Potential Link to Burkholderia Cepacia Bloodstream Infections
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10/5/2016
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5:50 PM
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FDA MedWatch RSS Feed
|
The effects of Burkholderia cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.
Full Article
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Twin-Pass Dual Access Catheters by Vascular Solutions: Recall - Potential for Excess Manufacturing Material At The Tip
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10/5/2016
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5:50 PM
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FDA MedWatch RSS Feed
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Excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.
Full Article
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Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating
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10/4/2016
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5:40 PM
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FDA MedWatch RSS Feed
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FDA requiring a Boxed Warning about the risk of HBV reactivation to be added to drug labels, directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment.
Full Article
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50mm 0.2 Micron Filters by Baxter: Recall - Potential for Missing Filter Support Membrane, Particulate Matter
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10/3/2016
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6:30 PM
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FDA MedWatch RSS Feed
|
Bacteria and/or particulate matter present in an unsterile solution could pass through to a compounded prepared solution, which could lead to adverse health consequences.
Full Article
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Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children
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9/30/2016
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6:00 PM
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FDA MedWatch RSS Feed
|
Adverse events reported to the agency, including seizures in infants and children who were given these products.
Full Article
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Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor by DePuy Synthes: Class I Recall - Possible Explosion Risk
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9/28/2016
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6:40 PM
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FDA MedWatch RSS Feed
|
Potential for the adaptors to produce extreme internal pressure, which may cause the device to explode. The use of affected products may cause serious adverse health consequences, including death.
Full Article
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Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance
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9/22/2016
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6:54 PM
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FDA Pet Health RSS Feed
|
Ocala, Florida - Wells Pharmacy Network ("WPN") is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry due to the Food and Drug Administration's ("FDA") concern over a lack of sterility assurance.
Full Article
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Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance
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9/22/2016
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6:50 PM
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FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.
Full Article
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Hyoscyamine Sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results
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9/15/2016
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3:20 PM
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FDA MedWatch RSS Feed
|
Adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation.
Full Article
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GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe
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9/9/2016
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6:07 PM
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FDA MedWatch RSS Feed
|
Affected product with detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal.
Full Article
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Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination
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9/8/2016
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12:20 PM
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FDA MedWatch RSS Feed
|
Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Full Article
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Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination
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9/7/2016
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9:17 PM
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FDA MedWatch RSS Feed
|
Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Full Article
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Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use
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9/7/2016
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6:40 PM
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FDA MedWatch RSS Feed
|
Using unproven ovarian cancer screening tests may be harmful for women with increased risk for developing ovarian cancer.
Full Article
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Kinetic Technologies and Kinetic Vet Announce the Voluntary Nationwide Recall of Hy-Optic, OptiVet and Optimend Due to Deficiencies in Sterility
|
9/2/2016
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9:00 PM
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FDA Pet Health RSS Feed
|
Kinetic Technologies and Kinetic Vet located in Lexington, KY has voluntarily recalled Hy-Optic ? lot # 10092015, OptiVet ? lot # 12032015 and Optimend ? lot # 01122015. This voluntary recall is the result of deficiencies in sterility, which may lead to deteriorating eye conditions, irritation and/or infection.
Full Article
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Mass Spectrometers by Sciex: Safety Communication - Incorrect Assignment of Test Results
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9/1/2016
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4:40 PM
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FDA MedWatch RSS Feed
|
Health care professionals may make inaccurate clinical diagnoses or inaccurate medical treatment decisions for patients by relying on incorrect results from the devices, which may lead to serious adverse health consequences.
Full Article
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Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas
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9/1/2016
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1:00 PM
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FDA MedWatch RSS Feed
|
Reports of intraoperative or postoperative bleeding and hematomas, some of which required additional intervention, and three patient deaths potentially related to this issue that occurred shortly after carotid endarterectomy surgery.
Full Article
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Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Serious Risks and Death
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8/31/2016
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4:01 PM
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FDA MedWatch RSS Feed
|
Combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system has resulted in serious side effects, including slowed or difficult breathing and deaths.
Full Article
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Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels
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8/30/2016
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8:30 PM
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FDA MedWatch RSS Feed
|
UPDATED 08/30/2016. Company press release with additional information added. Recall expanded to include all lots of DHZC-2 tablets.
Full Article
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Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards
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8/29/2016
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7:17 PM
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FDA MedWatch RSS Feed
|
Patients could take less than their intended lamotrigine dose, which may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.
Full Article
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Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates
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8/25/2016
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4:00 PM
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FDA MedWatch RSS Feed
|
Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.
Full Article
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Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination
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8/22/2016
|
|
3:45 PM
|
FDA MedWatch RSS Feed
|
Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.
Full Article
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Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter
|
8/19/2016
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|
5:00 PM
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FDA MedWatch RSS Feed
|
Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
Full Article
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Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister Pack
|
8/18/2016
|
|
6:20 PM
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FDA MedWatch RSS Feed
|
Risk of sub-therapeutic dose as well as potential microbial contamination.
Full Article
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Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination
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8/17/2016
|
|
6:15 PM
|
FDA MedWatch RSS Feed
|
UPDATED 8/16/2016. Recall expanded to include an additional lot. Product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups.
Full Article
|
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System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics: FDA Safety Communication - FDA Recommends Stop Using for Reprocessing Duodenoscopes
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8/17/2016
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1:30 PM
|
FDA MedWatch RSS Feed
|
Health care facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Full Article
|
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NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results
|
8/12/2016
|
|
11:20 PM
|
FDA MedWatch RSS Feed
|
The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
Full Article
|
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DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk
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8/12/2016
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|
6:00 PM
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FDA MedWatch RSS Feed
|
Tablets have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children.
Full Article
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Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination
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8/9/2016
|
|
12:00 PM
|
FDA MedWatch RSS Feed
|
Use of B. cepacia contaminated product could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Full Article
|
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AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown
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7/28/2016
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6:20 PM
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FDA MedWatch RSS Feed
|
Ventilator shutdown may cause serious adverse health consequences, including death.
Full Article
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Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects
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7/26/2016
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|
4:01 PM
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FDA MedWatch RSS Feed
|
Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.
Full Article
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HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance
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7/22/2016
|
|
6:15 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.
Full Article
|
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Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation
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7/22/2016
|
|
2:00 PM
|
FDA MedWatch RSS Feed
|
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death.
Full Article
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WEN by Chaz Dean Cleansing Conditioners: FDA Statement - Investigation of Adverse Event Reports
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7/19/2016
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5:00 PM
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FDA MedWatch RSS Feed
|
Reports of hair loss, hair breakage, balding, itching, and rash.
Full Article
|
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Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. Cepacia
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7/16/2016
|
|
4:00 AM
|
FDA MedWatch RSS Feed
|
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
Full Article
|
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INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR Results
|
7/12/2016
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|
7:30 PM
|
FDA MedWatch RSS Feed
|
Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution.
Full Article
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Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg: Recall - Undeclared Drug Ingredient
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7/5/2016
|
|
4:30 PM
|
FDA MedWatch RSS Feed
|
Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Full Article
|
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HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion
|
6/29/2016
|
|
4:20 PM
|
FDA MedWatch RSS Feed
|
Batteries may lose power prematurely due to faulty cells.
Full Article
|
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Purina Animal Nutrition Initiates Recall of Purina Medicated Sheep Feed due to Elevated Copper Level
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6/27/2016
|
|
3:02 PM
|
FDA Pet Health RSS Feed
|
Purina Animal Nutrition LLC of Arden Hills, Minnesota, is voluntarily recalling one lot of Purina Lamb Grower B30 Medicated Sheep Feed packaged in the green and white generic paper LAND O LAKES Feed bags.
Full Article
|
|
Radagast Pet Food, Inc. Is Voluntarily Recalling Four Lots Of Frozen Rad Cat Raw Diet® Due To Possibly Salmonella And Listeria Monocytogenes Health Risk
|
6/24/2016
|
|
12:50 AM
|
FDA Pet Health RSS Feed
|
Radagast Pet Food, Inc. (Portland, OR) has announced a voluntary recall of four lots of frozen Rad Cat Raw Diet products, sold in 8oz., 16oz., and 24oz. tubs, and free 1oz sample cups, due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes. Salmonella and Listeria monocytogenes can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Full Article
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Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings
|
6/14/2016
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|
2:00 PM
|
FDA MedWatch RSS Feed
|
Revised warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
Full Article
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Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk
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6/8/2016
|
|
6:20 PM
|
FDA MedWatch RSS Feed
|
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Full Article
|
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Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients
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6/7/2016
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|
6:55 PM
|
FDA MedWatch RSS Feed
|
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Full Article
|
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Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse
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6/7/2016
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|
1:00 PM
|
FDA MedWatch RSS Feed
|
Majority of reported problems occurred in individuals intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria.
Full Article
|
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Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk
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6/6/2016
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products.
Full Article
|
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St?ckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections
|
6/1/2016
|
|
5:55 PM
|
FDA MedWatch RSS Feed
|
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used.
Full Article
|
|
Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic Respiratory and Monitoring Solutions: Class I Recall - Potential Fire Risk
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5/27/2016
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|
2:55 PM
|
FDA MedWatch RSS Feed
|
Manufacturing defect causes an increase in temperature within battery that may cause a fire.
Full Article
|
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Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect
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5/26/2016
|
|
5:10 PM
|
FDA MedWatch RSS Feed
|
Y-shaped connector and the yellow tube may disconnect from each other prior to or during use. This could lead to blood or fluid leakage, which may result in serious adverse health consequences, including death.
Full Article
|
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Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death
|
5/19/2016
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|
4:00 AM
|
FDA MedWatch RSS Feed
|
Skin and nail fungal infections in otherwise healthy persons are not life-threatening, and so the risks associated with oral ketoconazole outweigh the benefits. Posted 05/19/2016
Full Article
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Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance
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5/18/2016
|
|
5:00 PM
|
FDA MedWatch RSS Feed
|
Administration of a drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death.
Full Article
|
|
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
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5/18/2016
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|
4:56 PM
|
FDA MedWatch RSS Feed
|
FDA is currently investigating this new safety issue. Patients should not stop or change their diabetes medicines.
Full Article
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Well Care Compounding Pharmacy Issues Voluntary Statewide Recall of All Sterile Compounded Products Due to Lack Of Assurance if Sterility Concerns
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5/17/2016
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|
11:45 PM
|
FDA Pet Health RSS Feed
|
Well Care Compounding Pharmacy, Las Vegas, Nevada is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to the Food and Drug Administration's (FDA) concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016.
Full Article
|
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SOS Telecom Products: Recall - Undeclared Drug Ingredient
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5/13/2016
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2:50 PM
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FDA MedWatch RSS Feed
|
Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Full Article
|
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BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries
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5/13/2016
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|
2:40 PM
|
FDA MedWatch RSS Feed
|
FDA urges health care professionals to purchase drug products only from legitimate suppliers.
Full Article
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|
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections
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5/12/2016
|
|
5:35 PM
|
FDA MedWatch RSS Feed
|
Serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.
Full Article
|
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Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions
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5/10/2016
|
|
4:01 PM
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FDA MedWatch RSS Feed
|
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death.
Full Article
|
|
Manna Pro Products Issues Limited Voluntary Recall of Chick Starter Medicated Distributed in California, Nevada, Oregon, and Hawaii
|
5/10/2016
|
|
3:30 PM
|
FDA Pet Health RSS Feed
|
Manna Pro Products, LLC is voluntarily recalling a single lot (MADE 11/23/15 WP-2) of Manna Pro Chick Starter Medicated, UPC 0 95668 10555 6, packaged in 25 pound bags because it may contain excessive salt. Symptoms of excessive salt intake include increased water consumption, anorexia, and weight loss, and may lead to death.
Full Article
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Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall - Defective Conductivity Sensors
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5/4/2016
|
|
2:30 PM
|
FDA MedWatch RSS Feed
|
The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.
Full Article
|
|
Beacon Tip Technology Catheters by Cook Medical: Recall - Polymer Degradation of the Catheter Tip
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5/4/2016
|
|
1:10 PM
|
FDA MedWatch RSS Feed
|
Degradation could lead to loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment.
Full Article
|
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Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems
|
5/3/2016
|
|
4:30 PM
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FDA MedWatch RSS Feed
|
Compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of
aripiprazole, and may result in harm to the patient and others if not recognized.
Full Article
|
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Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor)
|
5/2/2016
|
|
7:10 PM
|
FDA MedWatch RSS Feed
|
During transition from the name Brintellix to Trintellix, prescribers can reduce the risk of name confusion by including the generic name of the medication they are ordering, in addition to the brand name and indication for use.
Full Article
|
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Making It A Lifestyle, L.L.C. Supplements 3rd Degree, Black Gold X Advanced, and Black Label X: Recall - Undeclared Drug Ingredients
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5/2/2016
|
|
2:25 PM
|
FDA MedWatch RSS Feed
|
Undeclared sibutramine or sildenafil poses a threat to consumers.
Full Article
|
|
Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter
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4/26/2016
|
|
9:30 PM
|
FDA MedWatch RSS Feed
|
Administration of a solution containing glass particulate matter may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves.
Full Article
|
|
Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy
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4/26/2016
|
|
1:00 PM
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FDA MedWatch RSS Feed
|
Danish study shows possible increased risk of miscarriage. FDA advises cautious prescribing of oral fluconazole in pregnancy, until more is understood about this study.
Full Article
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Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall - Risk of Thermal Damage
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4/20/2016
|
|
8:30 PM
|
FDA MedWatch RSS Feed
|
Thermal damage may cause fire, resulting in smoke inhalation and minor burns.
Full Article
|
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March 2016 - Drug Safety Labeling Changes
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4/15/2016
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|
12:22 PM
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FDA MedWatch RSS Feed
|
Drug Safety Labeling Changes includes 35 products with revisions to Prescribing Information. Posted 04/15/2015
Full Article
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50 Percent Magnesium Sulfate Injection, USP by Hospira: Recall - Presence Of Particulate Matter
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4/14/2016
|
|
3:00 PM
|
FDA MedWatch RSS Feed
|
Administration may result in localized swelling, redness, pain at the site of administration or veins, allergic reactions to the foreign particle, microembolic effects as well as possible fetal harm.
Full Article
|
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Focus Diagnostics Laboratory Examination Kits: Class I Recall - Inaccurate Test Results
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4/14/2016
|
|
11:30 AM
|
FDA MedWatch RSS Feed
|
Inaccurate results may lead to improper patient treatment for HSV or GAS and may cause serious adverse health consequences, including death.
Full Article
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Super Herbs Capsules: Recall - Undeclared Drug Ingredients
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4/12/2016
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3:10 PM
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FDA MedWatch RSS Feed
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Product poses significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Full Article
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Guardian II Hemostasis Valves by Vascular Solutions, Inc: Recall - Risk of Air Leakage
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4/11/2016
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6:40 PM
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FDA MedWatch RSS Feed
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Air leakage may lead to an air embolism, which could result in serious injury or death.
Full Article
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Fetch 2 Aspiration Catheter by Boston Scientifi | |
