SUN PHARMACEUTICAL INDUSTRIES INC recalls Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Via

Recalled July 10, 2024 · FDA recall D-0582-2024 · SUN PHARMACEUTICAL INDUSTRIES

Hazard

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

Units

2088 vials

Sold at

Nationwide in the USA

Description

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

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.

Manufacturer(s)

SUN PHARMACEUTICAL INDUSTRIES INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →