Drug 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.
D-0643-2024
Product summary
- Event
- Event 95075
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2404 bottles
- Official record key
drug-enforcement:D-0643-2024
Official wording
Reason: Failed Dissolution Specifications: below specification results
Code information: Lot#: 17240105, Exp 12/31/2025
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications