Drug recall D-0430-2024
Product
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
Reason for recall
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Lots and codes
Lot #: 17230304, Exp. 12/31/2024.
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 6,528 bottles
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 26, 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