FDA Recall D-0582-2024

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class II Ongoing 681 days on record

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

Product

Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.

Lot / code: HAD2964A, Exp 7/31/2024

Quantity: 2088 vials

Reason for recall

CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

Recall record

Recall number: D-0582-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-07-02
Classified by FDA Center: 2024-07-03
FDA published: 2024-07-10
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

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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