Drug product
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10
D-1543-2020
Product summary
- Event
- Event 86280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 594 bottles
- Official record key
drug-enforcement:D-1543-2020
Official wording
Reason: CGMP Deviations
Code information: Lot #18641; Exp. 05/2021
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations