D-1384-2020 Class II Terminated
FDA drug recall D-1384-2020 was initiated by Lupin Pharmaceuticals Inc. on July 7, 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: 59,568 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 22, 2020
- Initiation Date
- July 7, 2020
- Termination Date
- December 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,568 bottles
Product Description
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 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 # G808293 Aug-20 G808284 Aug-20 G808285 Aug-20 G808343 Aug-20 G901201 Dec-20 G901202 Dec-20 G906915 Jul-21 G906913 Jul-21 G906914 Jul-21 G002135 Jan-22 G002849 Feb-22