FDA Recall D-0092-2024

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 934 days on record

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

Product

Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.

Lot / code: Lot # 17230388, Exp. 01/31/2025

Quantity: 16,944 bottles

Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

Recall record

Recall number: D-0092-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2023-10-23
Classified by FDA Center: 2023-11-07
FDA published: 2023-11-15
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): RANOLAZINE
Generic name(s): RANOLAZINE
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-319, 68462-320
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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