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Testosterone Products: Drug Safety Communication
[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.] [Posted 03/03/2015] AUDIENCE: Health Professional, Endocrinology, Urology, Family Practice, Patient ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling…
HeartWare Ventricular Assist System Controllers by HeartWare International: Recall
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Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial by Heritage Pharmaceuticals: Recall
[Posted 02/25/2015] AUDIENCE: Pharmacy ISSUE: Heritage Pharmaceuticals Inc. announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Heritage has initiated this…
Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit by GE Healthcare: Class I Recall
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MAQUET Servo Humidifier 163 by Teleflex Medical: Class I Recall
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Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall
[Posted 02/24/2015] AUDIENCE: Emergency Medicine, Anesthesiology, Risk Manager ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated…
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication
[Posted 02/19/2015] AUDIENCE: Gastroenterology, Surgery, Nursing, Risk Manager, Biomedical Engineering, Patient ISSUE: The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and…
Ketorolac Tromethamine Injection by Hospira: Recall
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Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall
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