Drug product
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02
D-1089-2014
Product summary
- Event
- Event 67433
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2528 bottles
- Official record key
drug-enforcement:D-1089-2014
Official wording
Reason: Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Code information: Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet