FDA Recall D-0643-2024

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 652 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot#: 17240105, Exp 12/31/2025

Quantity: 2404 bottles

Reason for recall

Failed Dissolution Specifications: below specification results

Recall record

Recall number: D-0643-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Nationwide USA
Recall initiated: 2024-07-31
Classified by FDA Center: 2024-08-23
FDA published: 2024-09-04
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): INDOMETHACIN
Generic name(s): INDOMETHACIN
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-325
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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