Drug product
Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
D-0100-2019
Product summary
- Event
- Event 80790
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82,291 bottles
- Official record key
drug-enforcement:D-0100-2019
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 #: 1139500A, Exp 04/2019; 1240343A, 1248901M, 1256614M, Exp 05/2020
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.