Drug product
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
D-1384-2020
Product summary
- Event
- Event 85998
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59,568 bottles
- Official record key
drug-enforcement:D-1384-2020
Official wording
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Foreign material or chemical contamination
NDMA) impurity
-
Manufacturing or process control
CGMP Deviations