Drug product
Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02
D-0482-2017
Product summary
- Event
- Event 76457
- Status
- Terminated
- Classification
- Class II
- Quantity
- 630 pills (21 bottles x 30 pills per HDPE bottle)
- Official record key
drug-enforcement:D-0482-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # B0129373-021916; Exp. 10/17 00591-0900-30 Original NDC 52125-0764-02 RemedyRepack NDC
Distribution pattern: Product was distributed to a sold customer in FL.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications