Drug product
Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02
D-0924-2018
Product summary
- Event
- Event 80440
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2508 bottles
- Official record key
drug-enforcement:D-0924-2018
Official wording
Reason: Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Code information: Lot #: JKT0042A, Exp 1/2021
Distribution pattern: AZ
Derived failure modes
-
Foreign material or chemical contamination
foreign substance