This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
News|Articles|June 4, 2020
Amneal Pharmaceuticals Recalls Metformin Hydrochloride
Author(s)Pharmaceutical Technology Editors
The company is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, because of the detection of N-Nitrosodimethylamine.
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Amneal Pharmaceuticals (Bridgewater, NJ)
Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg are used as an adjunct to improve blood sugar control in adults with type 2 diabetes mellitus. NDMA is classified as a probable human carcinogen and is a known environmental contaminant.
The affected lots were distributed nationwide in the United States directly to wholesalers, distributors, retailers, and repackagers. The recall does not apply to the company’s Metformin Hydrochloride Immediate Release Tablets, USP.
The company has not received any reports of adverse events. Adverse events may be reported to FDA via the agency’s MedWatch program.
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