Metformin Hydrochloride Extended-release Tablets USP recalled over manufacturing violations
- Recall date
- June 11, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Lupin Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmace…
- Recall number
- D-1334-2020
- FDA classification
- Class II
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Product was distributed throughout the United States.
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)
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