FDAHealthJuly 31, 2024
Glenmark Pharmaceuticals Inc., USA — 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, Manufact
⚠️ Failed Dissolution Specifications: below specification results
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 31, 2024
Nationwide USA
What's affected?
- 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.
- Brand
- INDOMETHACIN
- UPC
- 0368462325605
- Lot code
- 17240105
Additional details
Lot#: 17240105, Exp 12/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2404 bottles.
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