Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd
Recalled December 11, 2024 · FDA recall D-0098-2025 · Glenmark Pharmaceuticals Inc., USA
Hazard
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. · FDA Class II
Units
7296 bottles
Sold at
Nationwide in the USA
Description
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
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.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →