FDA recall D-0582-2024

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.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-07-02

Report date

2024-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0582-2024