Class IIOngoing

Indomethacin Extended-Release Capsules recall

FDA recall D-0643-2024 · initiated Jul 31, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Dissolution Specifications: below specification results

Details

Product: Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Recalling company: Glenmark Pharms
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide USA
Initiated: Jul 31, 2024
FDA report date: Sep 4, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0643-2024 ↗

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