FDA-Drug2024-12-11Class II
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, 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 16714-553-01.
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
5232 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, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0096-2025Don't want to check this manually?
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