FDAFDA · Food and drugs·Recall number D-0643-2024

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.

Name: 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.
Brand: INDOMETHACIN

Published September 4, 2024 · Recall initiated: July 31, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Dissolution Specifications: below specification results

What to do

Voluntary: Firm initiated

Recall details

Brand: INDOMETHACIN
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Distributor: Nationwide USA
UPC: 0368462325605
Lot: Lot#: 17240105, Exp 12/31/2025
Risk classification: Class II
Area (FDA): drug
Country: United States

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