Drug recall D-1334-2020
Product
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)
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Lots and codes
Batch # G901203, exp. date 12/2020
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 6,540 bottles
- Distribution
- Product was distributed throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 11, 2020
- Terminated
- December 23, 2021
Related products
- NDC 68180-336 Metformin Hydrochloride · Metformin Hydrochloride 500 mg/1 · Lupin Pharmaceuticals, Inc.