Class II
Terminated
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- July 7, 2020
- Posted
- July 22, 2020
- Recall Number
- D-1382-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 64,344 bottles
- Firm Location
- Baltimore, MD, United States
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Distribution
Product was distributed throughout the United States.
Lot / Code Info
Batch# G808201 Aug-20 G808202 Aug-20 G808200 Aug-20 G900935 Dec-20 G901311 Dec-20 G900957 Dec-20 G900958 Dec-20 G901006 Dec-20 G904803 May-21 G904804 May-21 G906551 Jul-21 G906552 Jul-21 G907375 Aug-21 G908605 Oct-21 G908604 Oct-21 G002108 Jan-22 G002109 Jan-22 G002559 Feb-22 G002560 Feb-22
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