Drug recall D-0582-2024

Class II Ongoing reported Jul 10, 2024

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.

Reason for recall

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

Lots and codes

HAD2964A, Exp 7/31/2024

Recall details

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
Quantity
2088 vials
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
July 2, 2024

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