D-0093-2025 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
- 34848 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: 17222544, Exp. Date 11/30/2024 ; 17230784, Exp Date 03/31/2025; 17231080, Exp. Date 04/30/2025