Drug Recall: 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
Glenmark Pharmaceuticals Inc., USA · March 26, 2024
Reason for Recall
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Product Description
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
Distribution
Nationwide in the US
States Affected
NATIONWIDE
Quantity Affected
6,528 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0430-2024
Status: ongoing
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