Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Digital Temple Thermometer (DTT) by K-Jump Health Co., Ltd.: Recall - Inaccurate Temperature Display Manufacturing problem causes the affected thermometers to display temperatures that are lower than actual body temperatures, which may cause the user or caregiver of the user to delay or forego seeking appropriate care. Posted 12/01/2015 RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific: Recall - Wires May Break and Separate from the Rotablator System The use of affected product may cause serious adverse health consequences, including death. Posted 11/27/2015 Compounded Multivitamins by Glades Drugs: Voluntary Recall - High Amounts of Vitamin D3 (Cholecalciferol) Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated. Posted 11/25/2015
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.