Device and Drug Alerts

FDA: Mylan Initiates Voluntary Nationwide Recall of Four Lots of Amiodarone HCl Injection, USP and Tranexamic Acid Injection, USP Due to Carton Label Mix-Up
FDA: Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurit
FDA: False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers
Arrow International Inc Recalls Arrow AutoCAT2 and AC3 Optimus
FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem
FDA: Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers
FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
FDA Class 1 Recall: Endologix Inc. Recalls Ovation iX Abdominal Stent Graft Systems
FDA Revokes Emergency Use Authorization for Chembio Antibody Test
FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine