FDA Safety Information and Adverse Event Reporting
Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
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
Bullet Proof: Public Notification - Undeclared Drug Ingredient
Lightning Rod Capsules: Recall - Undeclared Drug Ingredient
Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected
Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit
Covidien Surgical Stapler Reloads: FDA Safety Communication - Devices Stolen Before They Were Sterilized
Cardinal Health: Class 1 Recall - Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit
Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches
Kadcyla (ado-trastuzumab emtansine): Drug Safety Communication - Potential Medication Errors Resulting from Name Confusion
American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient
Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage

FDA Safety Information and Adverse Event Reporting

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May 18, 2013
If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection.
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