RecallDepth
Class II Ongoing

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.

This recall is currently active, issued September 4, 2024. It was issued by Glenmark Pharmaceuticals Inc., Usa.

Company
Glenmark Pharmaceuticals Inc., Usa
Recall Initiated
July 31, 2024
Posted
September 4, 2024
Recall Number
D-0643-2024
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
2404 bottles
Firm Location
Mahwah, NJ, United States
Official Source
View on FDA website ↗

Reason for Recall

Failed Dissolution Specifications: below specification results

Distribution

Nationwide USA

Lot / Code Info

Lot#: 17240105, Exp 12/31/2025

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