Drug product
Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
D-0098-2019
Product summary
- Event
- Event 80790
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,225 bottles
- Official record key
drug-enforcement:D-0098-2019
Official wording
Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Code information: Lot #: 1237868A, 1248900A, Exp 5/2020
Distribution pattern: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Derived failure modes
-
Unknown
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.