Denton Pharma, Inc.: Metformin Hydrochloride Extended-Release Tablets USP 750
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: N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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