FDA Recall D-0350-2024

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class II Ongoing 829 days on record

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

Product

Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.

Lot / code: Lot #s: MHD0606A, MHD0612A, Exp. 04/30/2024; MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, Exp. 05/31/2024; MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, Exp. 06/30/2024; MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A, Exp. 07/31/2024; MHD1081A, MHD1082A, MHD1087A Exp. 09/30/2024.

Quantity: 54,960 bottles

Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

Recall record

Recall number: D-0350-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the U.S.
Recall initiated: 2024-02-05
Classified by FDA Center: 2024-02-23
FDA published: 2024-03-06
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): MESALAMINE
Generic name(s): MESALAMINE
Manufacturer(s): Sun Pharmaceutical Industries Inc.
NDC(s): 63304-089
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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