Decitabine for Injection 50mg per vial recall

Why it was recalled

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

Details

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.

Recalling company

Sun Pharm Industries

Classification

Class II

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

Nationwide in the USA

Initiated

Jul 2, 2024

FDA report date

Jul 10, 2024