Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening. Posted 09/22/2016 Hyoscyamine Sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results Adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation. Posted 09/15/2016 GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe Affected product with detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. Posted 09/09/2016 Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection. Posted 09/08/2016 Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection. Posted 09/07/2016 Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use Using unproven ovarian cancer screening tests may be harmful for women with increased risk for developing ovarian cancer. Posted 09/07/2016 Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical: Recall - Raw Materials Issue UPDATED 09/06/2016 Recall classified as Class I. Recalled Device and Discontinuation of the Product line. Originally Posted 08/15/2016 Drug Safety Labeling Changes (SLC) Database
Safety labeling change (SLC) data on the Web is now available to view, search, and download. Visit the new database to obtain the most recent label changes. Posted 09/01/2016
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.