Glenmark Pharmaceuticals Inc., USA recalls Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count b
Recalled September 4, 2024 · FDA recall D-0643-2024 · Glenmark Pharmaceuticals Inc., USA
Hazard
Failed Dissolution Specifications: below specification results · FDA Class II
Units
2404 bottles
Sold at
Nationwide USA
Description
Failed Dissolution Specifications: below specification results
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.
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →