Drug recall D-0643-2024

Class II Ongoing reported Sep 4, 2024

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 for recall

Failed Dissolution Specifications: below specification results

Lots and codes

Lot#: 17240105, Exp 12/31/2025

Recall details

Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Quantity
2404 bottles
Distribution
Nationwide USA
Type
Voluntary: Firm initiated
Recall initiated
July 31, 2024

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