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FDA Warnings

Latest FDA Updates

Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

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

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

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

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

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

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

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

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.

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

UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.

Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient

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.


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