The U.S. Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse rea
Similar Posts
Guidance Snapshot Pilot
Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program is intended to increase awareness for FDA guidance documents to support the efficient application of the documents’ recommendations.Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs
Alcon recalls Custom Pak Ophthalmic Procedure Packs due to incomplete seals that may compromise sterility. Check lot numbers, recall instructions.Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods
Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.Examples of Accepted Emerging Technologies
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.Zhejiang Huahai Pharmaceutical Co., Ltd. – 707145 – 06/06/2025
CGMP/Finished Pharmaceuticals/AdulteratedUnichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling
08/27/2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam
