Drug product
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
D-0192-2025
Product summary
- Event
- Event 96082
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,804 bottles
- Official record key
drug-enforcement:D-0192-2025
Official wording
Reason: Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Code information: Lot #: 4911311A, Exp. Date: 11/2025
Distribution pattern: Distributor in OH.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets