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Class II · ModerateActive recall

Decitabine for Injection 50mg per vial

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberHAD2964A, Exp 7/31/2024
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India foreign manufacturer
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
NDC47335-361-40
Show the full FDA record
Full product labelDecitabine 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 firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the USA
Quantity2088 vials
Recall initiated2024-07-02
Report date2024-07-10
Recall completed—
Recall numberD-0582-2024
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.