Why it was recalled
Failed Dissolution Specifications: below specification results
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.
Lot numbers, UPCs & expiration codes
Lot#: 17240105, Exp 12/31/2025
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0643-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 31, 2024
- FDA report date
- Sep 4, 2024
- Quantity
- 2404 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0643-2024, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95075
- Address
- 750 Corporate Dr
- Code information
- Lot#: 17240105, Exp 12/31/2025
- Postal code
- 07430-2009
- Report date
- Sep 4, 2024
- Product type
- Drugs
- Recall number
- D-0643-2024
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 2404 bottles
- Reason for recall
- Failed Dissolution Specifications: below specification results
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jul 31, 2024
- Center classification date
- Aug 23, 2024