Drug product
Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
D-0014-2016
Product summary
- Event
- Event 72308
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,284 bottles
- Official record key
drug-enforcement:D-0014-2016
Official wording
Reason: Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Code information: Lot: 1037736A, Exp 03/18
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out-of-Specification