Drug recall D-0094-2025
Product
Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.
Reason for recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Lots and codes
Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 12,864 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 1, 2024
Related products
- Diltiazem Hydrochloride – drug information
- NDC 68462-851 Diltiazem Hydrochloride · Diltiazem Hydrochloride 90 mg/1 · GLENMARK PHARMACEUTICALS INC., USA
- NDC 68462-562 Diltiazem Hydrochloride · Diltiazem Hydrochloride 120 mg/1 · GLENMARK PHARMACEUTICALS INC., USA
- NDC 68462-850 Diltiazem Hydrochloride · Diltiazem Hydrochloride 60 mg/1 · GLENMARK PHARMACEUTICALS INC., USA