Drug product

Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, 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 16714-555-01.

D-0098-2025

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 #:17222547, Exp. Date, 11/30/2024; 17230598, 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