Recalls / Class II

Class IID-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.

Affected lot / code info

HAD2964A, Exp 7/31/2024

Why it was recalled

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

Recalling firm

Firm

SUN PHARMACEUTICAL INDUSTRIES INC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2 Independence Way, N/A, Princeton, New Jersey 08540-6620

Distribution

Quantity

2088 vials

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-07-02

FDA classified

2024-07-03

Posted by FDA

2024-07-10

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0582-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.