Drug product
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.
D-0096-2025
Product summary
- Event
- Event 95660
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5232 bottles
- Official record key
drug-enforcement:D-0096-2025
Official wording
Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Code information: Lot #: 17222544, Exp 11/30/2024.
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