MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Injectable Products by Mylan: Recall - Presence of Particulate Matter Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Posted 04/24/2015 Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue. Posted 04/24/2015 Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing The results obtained from these test kits have not been demonstrated to be accurate and should not be used as diagnostic tests for Ebola infection. Posted 04/23/2015 Mucinex Fast-MAX Products: Recall - Incorrect Labeling Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. Posted 04/22/2015 Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died. Posted 04/17/2015 VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub Separation could result in required intervention to prevent permanent impairment or damage. Posted 04/16/2015 March 2015 Safety Labeling Changes includes 67 products with revisions to Prescribing Information. Posted 04/15/2015 Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter Particles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. Posted 04/10/2015 Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada. Posted 04/02/2015
FDA Approved Safety Information
DailyMed (National Library of Medicine)
Current Drug Prescribing Information. (NOTE: Drugs marked "unapproved" on this site have not been reviewed by FDA for safety and efficacy, and their labeling has not been approved.)
Paper handouts that come with many prescription medicines. Medication Guides address issues specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events.
Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.