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.

Recall Number: D-0582-2024

Firm: SUN PHARMACEUTICAL INDUSTRIES INC

Classification: Class II

Status: Ongoing

Report Date: 20240710

Initiation Date: 20240702

Termination Date:

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

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.