FDA-Drug2024-04-10Class II
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Sold states
Nationwide in the US
Affected count
6,528 bottles
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0430-2024Don't want to check this manually?
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