[Posted 10/13/2016] AUDIENCE: Risk Manager, Cardiology, Surgery, Infectious Disease, Nursing ISSUE: FDA is updating its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the StÓ§ckert 3T Heater-Cooler System (3T) in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations…
Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication
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I.V. Flush Syringes by Nurse Assist: Recall
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Twin-Pass Dual Access Catheters by Vascular Solutions: Recall
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Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication
[Posted 10/04/2016] AUDIENCE: Infectious Disease, Gastroenterology, Patient ISSUE: The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV…
50mm 0.2 Micron Filters by Baxter: Recall
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Homeopathic Teething Tablets and Gels: FDA Warning
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Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor by DePuy Synthes: Class I Recall
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Sterile Products by Wells Pharmacy Network: Recall
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Hyoscyamine Sulfate 0.125mg by Virtus Pharmaceuticals: Recall
[Posted 09/15/2016] AUDIENCE: Pharmacy, Gastroenterology, Pulmonology, Patient ISSUE: Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were…