Drug product
Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, 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-0372-2021
Product summary
- Event
- Event 87869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50868 bottles
- Official record key
drug-enforcement:D-0372-2021
Official wording
Reason: Presence of foreign substance: identified as activated carbon.
Code information: Lots #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A,JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A & JKX3224A, Exp 6/2032; JKX3211A, JKX3212A, Exp 7/2023.
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance