Class II Recall

Glenmark Pharmaceuticals Inc., USA

Product
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, 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 16714-554-01.
Reason
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Classification
Class II
Status
Ongoing
Lot
Lot #: 17222452, Exp Date 11/30/2024; 17230607, Exp Date 02/28/2025.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.