FDA Safety Information and Adverse Event Reporting
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication
May 2013
Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets
Symbios GOPump and GOBlock Kits: Class 1 Recall - Potential for Excessive High Flow Rates
Bethel Nutritional Consulting, Inc. Bethel 30: Recall: Undeclared Drug Ingredient.
Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected
Nephron Pharmaceuticals Corp. EZ Breathe Atomizer: Class 1 Recall - Washer Could Become Dislodged
Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use in Pre-term Labor
Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials
Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall - Complaints of Delivery System Tip Separation
Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials
Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result
All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance
Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance
Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses
Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy
The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products
SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient

FDA Safety Information and Adverse Event Reporting

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May 21, 2013
Particulate matter in parenteral drugs has been recognized as a potential health hazard.
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