D-0430-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 10, 2024
- Initiation Date
- March 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,528 bottles
Product Description
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.
Distribution Pattern
Nationwide in the US
Code Information
Lot #: 17230304, Exp. 12/31/2024.