Sun Pharmaceutical recalls Decitabine injection vials due to potential microbial contamination. This drug is for IV use only and requires a prescription. Affected units have specific NDC and expiration dates.
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Sun Pharmaceutical is recalling Decitabine injection vials that may have microbial contamination. This could pose a risk to patients receiving the drug through intravenous infusion. The recall affects specific vials with the NDC 47335-361-40 and expiration date 7/31/2024.
The recall is due to a manufacturing issue where the microbial count in the drug was outside acceptable limits. This could lead to potential infections if the medication is administered to patients. The issue occurred during the production of the unfiltered bulk drug.
Patients prescribed Decitabine injections by a healthcare provider are affected. Those using the recalled vials with NDC 47335-361-40 are at risk.
Check for the NDC number 47335-361-40 on the vial label. The vials were distributed by Sun Pharmaceutical Industries, Inc. and expire by July 31, 2024.
Look for the NDC number 47335-361-40 on the vial label to identify affected units.
The recall indicates a potential microbial contamination issue, so affected vials should not be used.
Check the vial label for the NDC number 47335-361-40 and contact your healthcare provider for guidance.
The recalled vials have the NDC number 47335-361-40 and expire by July 31, 2024.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0582-2024 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0582-2024 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
