FDAFDA · Food and drugs·Recall number D-1334-2020
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)
Published July 1, 2020 · Recall initiated: June 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Product was distributed throughout the United States.
- UPC
- 0368180337072
- Lot
- Batch # G901203, exp. date 12/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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