D-0096-2025 Class II Ongoing
FDA drug recall D-0096-2025 was initiated by Glenmark Pharmaceuticals Inc., USA on November 1, 2024 and is designated Class II. Reason for recall: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. The recall status is ongoing. Affected quantity: 5232 bottles.
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
- 5232 bottles
Product Description
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.
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 #: 17222544, Exp 11/30/2024.