Drug product

Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.

D-0094-2025

November 01, 2024

Class II

Product summary

Reason: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Code information: Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025

Distribution pattern: Nationwide in the USA

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

N-nitroso-Desmethyl-Diltiazem impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

cGMP Deviations