Recall: D-0643-2024

Class II - Potentially Harmful

Class IIClassification

2024-07-31Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

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.

Reason

Failed Dissolution Specifications: below specification results

Distribution

Nationwide USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.