Two lots of extended-release metformin voluntarily recalled in US
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Two lots of extended-release metformin voluntarily recalled in US Bayshore Pharmaceuticals is voluntarily recalling two lots of its metformin extended-release tablet products due to detection of NDMA* as an impurity, says the US FDA. The two lots of 1000-count bottles of metformin being recalled (within expiry and to the consumer level) include 500mg extended-release tablets (lot number 18641) and 750mg extended-release tablets (lot number 18657), which were manufactured by Beximco Pharmaceuticals in Bangladesh in June 2019 for subsequent distribution in the US by Bayshore Pharmaceuticals. Initially, Bayshore Pharmaceuticals was notified by the US FDA that its testing of the one above-mentioned lot of 750mg product contained NDMA levels above the Acceptable Daily Intake Limit (ADI) and consequently, the FDA recommended recall of this lot. After agreeing to this recall, Bayshore Pharmaceuticals took further precautionary measures and tested eight lots of metformin extended-release tablets that used the same active pharmaceutical ingredient (API) of the failed 750mg lot. It was from this testing that Bayshore Pharmaceuticals decided to recall lot 18641 of the 500mg metformin extendedrelease tablets. However, the FDA did note that "to date, neither Bayshore nor Beximco have received any reports of adverse events related to use of the product". The company is in the process of notifying affected customers (by phone or recall notifications), and is arranging its product recall processor (Qualanex LLC) to provide the materials needed for returning the recalled products, and instructions for reimbursement. * NDMA = N-nitrosodimethylamine; classified as a probable human carcinogen US Food and Drug Administration. 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) Impurity. Internet Document : 20 Aug 2020. Available from: URL: https://www.fda.gov/safety/recalls803500432 market-withdrawals-safety-alerts/bayshore-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
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Reactions 5 Sep 2020 No. 1820
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