Recalls / Class II
Class IID-0643-2024
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.
- Brand name
- Indomethacin
- Generic name
- Indomethacin
- Active ingredient
- Indomethacin
- Route
- Oral
- NDC
- 68462-325
- FDA application
- ANDA203501
- Affected lot / code info
- Lot#: 17240105, Exp 12/31/2025
Why it was recalled
Failed Dissolution Specifications: below specification results
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 2404 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2024-07-31
- FDA classified
- 2024-08-23
- Posted by FDA
- 2024-09-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0643-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.