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FDARecalled Dec 11, 2024 · #D-0093-2025

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...

Hazard

Class II — temporary health risk

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Description

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. Classification: Class II Distribution: Nationwide in the USA

Product details

Product
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.
Type
Drugs
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Model numbers
UPCs