D-0095-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2024
- Initiation Date
- November 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25584 bottles
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.
Reason for Recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 17222470, 17230680, 17222547, Exp. Date 11/30/2024; 17230304, Exp. Date, 12/31/2024; 17230598, Exp. Date, 02/2025.