D-0643-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- September 4, 2024
- Initiation Date
- July 31, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2404 bottles
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: below specification results
Distribution Pattern
Nationwide USA
Code Information
Lot#: 17240105, Exp 12/31/2025