US FDA

The U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older

Richie Pharmacal Company, Inc – 12/12/2024. Country: United States. Record Type: 483

Foster City, Calif., September 20, 2024 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in

Sterling Distributors, LLC – 03/06/2025. Country: United States. Record Type: 483

Pure Indulgence Aesthetics – 12/12/2025. Country: United States. Record Type: 483

A2A integrated Logistics Inc – 02/24/2025. Country: United States. Record Type: 483

FDA is hosting a virtual Information Session on Generic Drug Research Needs & Opportunities for fiscal year (FY) 2026 on Wednesday, January 21, 2026.

HARTFORD — The Connecticut Department of Consumer Protection Food and Standards Division is warning the public that Carrot Top Country Kitchens LLC, DBA Carrot Top Kitchens of Bridgeport (formerly Redding), is recalling 5 varieties of hummus due to undeclared sesame.

Sonoma, CA — Primavera Nueva Inc. is voluntarily recalling certain lots of its 4-count tamales because the products have the potential to be contaminated with Listeria monocytogenes, an organism which

Alembic Pharmaceuticals Limited – 02/06/2021. Country: India. Record Type: 483

Alembic Pharmaceuticals Limited – 11/10/2021. Country: India. Record Type: 483

CDER has established a meeting program called the Emerging Drug Safety Technology Meeting (EDSTM) program. Learn more.