Drug product
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
D-0095-2025
Product summary
- Event
- Event 95660
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 25584 bottles
- Official record key
drug-enforcement:D-0095-2025
Official wording
Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Code information: Lot #: 17222470, 17230680, 17222547, Exp. Date 11/30/2024; 17230304, Exp. Date, 12/31/2024; 17230598, Exp. Date, 02/2025.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-Desmethyl-Diltiazem impurity
-
Manufacturing or process control
cGMP Deviations