Drug Recall: 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, Manu
SUN PHARMACEUTICAL INDUSTRIES INC · July 2, 2024
Reason for Recall
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Product Description
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.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
2088 vials
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0582-2024
Status: ongoing
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