Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
34848 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Product description
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.
Code / lot info
Lot #s: 17222544, Exp. Date 11/30/2024 ; 17230784, Exp Date 03/31/2025; 17231080, Exp. Date 04/30/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.