MedWatch Safety Alert

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FDA MedWatch Safety Alerts
Updated: 4 hours 34 min ago

Octagam [Immune Globulin Intravenous (human)] 10 Percent Liquid Preparation]: Voluntary Market Withdrawal

12 hours 15 min ago
Suspend further administration of octagam 10% from production lots K724B8541 and K725A8541.

Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

Fri, 10/20/2017 - 22:00
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

Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected

Thu, 10/19/2017 - 13:30
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.

A1 Slim by Kiriko: Recall - Undeclared Drug Ingredients

Fri, 10/06/2017 - 22:00
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.

Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures

Fri, 10/06/2017 - 09:00
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.

Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis

Tue, 10/03/2017 - 13:00
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.

Infant Sleep Positioners: FDA Warning - Risk of Suffocation

Tue, 10/03/2017 - 08:00
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.

Endovascular Graft Systems: Letter to Health Care Providers - Type III Endoleaks Associated with Use

Thu, 09/28/2017 - 09:00
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.

Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Risk of Blocked Guidewire Lumen Preventing Balloon Utilization

Tue, 09/26/2017 - 05:00
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.