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-0472-2024
Product summary
- Event
- Event 94440
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,264 bottles
- Official record key
drug-enforcement:D-0472-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 17221312, Exp. 5/31/2024
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications