Drug Enforcement D-0094-2025

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

Status

Ongoing

Classification

Class II

Report Date

December 11, 2024

Termination Date

—

Product Information

Product description
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.
Product quantity
12,864 bottles
Reason for recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0094-2025
Event ID
95660
Recall initiation date
November 1, 2024
Center classification date
December 3, 2024
Code info
Lot #s 17222452, Exp. Date, 11/30/2024; 17230607, Exp. Date 02/28/2025
More code info
—