Drug product
Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
D-0099-2019
Product summary
- Event
- Event 80790
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,397 bottles
- Official record key
drug-enforcement:D-0099-2019
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 #: 1210888A, Exp 03/2019
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.