Drug product
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
D-1095-2023
Product summary
- Event
- Event 92859
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1,200 bottles
- Official record key
drug-enforcement:D-1095-2023
Official wording
Reason: Subpotent: Out of Specification for Assay Test at the 3-month time point.
Code information: Batch # 19224744
Distribution pattern: nationwide in the U.S.
Derived failure modes
-
Potency or specification failure
Subpotent