Denton Pharma, Inc.: Metformin Hydrochloride Extended-Release Tablets, USP 500
Recall reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer). Recalled by Denton Pharma, Inc.. Distribution: Indiana - Nationwide.. Classification (Class II — potential health risk). Affected lots/NDC/dates: a) 30 count: N107051905, exp 10/31/2020; N107052002, N107052005, exp 9/30/2021 b) 60 count: N107051907, exp 10/31/. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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