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FDA MedWatch Safety Alerts
Undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Posted: December 14, 2017, 1:00 pm
Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues
The use of impacted alcohol prep pads could result in adverse events such as infections.
Posted: December 5, 2017, 3:00 pm
Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems
UPDATED 12/05/2017. Anyone currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis.
Posted: December 5, 2017, 12:30 pm
Potential for fading print, with more effect on the expiration dating on the patient tear off portion of the vial label.
Posted: December 1, 2017, 1:30 pm
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.
Posted: December 1, 2017, 1:10 pm
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.
Posted: November 28, 2017, 2:00 pm
Use of the affected product potentially could result in a risk of infection, especially in an immunocompromised patient.
Posted: November 27, 2017, 3:10 pm
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets
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
Posted: November 17, 2017, 5:00 am
Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
Posted: November 15, 2017, 6:20 pm
Uloric (febuxostat): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death
Preliminary safety trial results in over 6,000 patients with gout being evaluated.
Posted: November 15, 2017, 4:00 pm
Injectable Silicone for Body Contouring and Enhancement: FDA Safety Communication - FDA Warns Against Use
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.
Posted: November 14, 2017, 3:00 pm
Compounded Glutamine, Arginine, and Carnitine Product for Injection by United Pharmacy: Compounding Risk Alert - FDA Investigates Two Adverse Events
Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences.
Posted: November 8, 2017, 8:00 pm
Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action - Incorrect Artwork on Packaging
If the user incorrectly places the defibrillation electrodes, it may result in ineffective energy delivery to the patient and serious injury or death.
Posted: November 6, 2017, 1:30 pm
Ridge Properties DBA Pain Relief Naturally Products: Recall - Manufacturing Concerns at the Facility
Risk of decreased quality and consistency (i.e., the safety, identity, strength, quality and purity)
Posted: November 6, 2017, 1:00 pm
Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market Withdrawal
Suspend further administration of octagam 10% from production lots K724B8541 and K725A8541.
Posted: October 23, 2017, 12:00 pm
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
Posted: October 21, 2017, 4:00 am
Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected
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.
Posted: October 19, 2017, 7:30 pm
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
Posted: October 7, 2017, 4:00 am
Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures
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.
Posted: October 6, 2017, 3:00 pm
Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.
Posted: October 3, 2017, 7:00 pm