Drug recall D-0093-2025
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.
Reason for recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Lots and codes
Lot #s: 17222544, Exp. Date 11/30/2024 ; 17230784, Exp Date 03/31/2025; 17231080, Exp. Date 04/30/2025
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 34848 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