Drug product
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
D-0430-2024
Product summary
- Event
- Event 94280
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,528 bottles
- Official record key
drug-enforcement:D-0430-2024
Official wording
Reason: Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Code information: Lot #: 17230304, Exp. 12/31/2024.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
Out of Specification