Drug product
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.
D-0093-2025
Product summary
- Event
- Event 95660
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34848 bottles
- Official record key
drug-enforcement:D-0093-2025
Official wording
Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Code information: Lot #s: 17222544, Exp. Date 11/30/2024 ; 17230784, Exp Date 03/31/2025; 17231080, Exp. Date 04/30/2025
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