FDA-Drug2024-12-11Class II
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.
Glenmark Pharmaceuticals Inc., USA
Hazard
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Sold states
Nationwide in the USA
Affected count
34848 bottles
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0093-2025Don't want to check this manually?
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