D-1334-2020 Class II Terminated
FDA drug recall D-1334-2020 was initiated by Lupin Pharmaceuticals Inc. on June 11, 2020 and is designated Class II. Reason for recall: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level The recall status is terminated (terminated December 23, 2021). Affected quantity: 6,540 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2020
- Initiation Date
- June 11, 2020
- Termination Date
- December 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,540 bottles
Product Description
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
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Batch # G901203, exp. date 12/2020