Decitabine for Injection 50mg per vial recall
FDA recall D-0582-2024 · initiated Jul 2, 2024
SUN PHARMACEUTICAL INDUSTRIES INC recalled Decitabine for Injection 50mg per vial in Jul 2024 — an FDA Class II recall (D-0582-2024) because CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2088 vials
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
Frequently asked
- Was Decitabine for Injection 50mg per vial recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Decitabine for Injection 50mg per vial in Jul 2024 — an FDA Class II recall (D-0582-2024) because CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Decitabine for Injection 50mg per vial recalled?
- Per the FDA enforcement record, the reason for recall D-0582-2024 was: CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
- Is a recalled Decitabine for Injection 50mg per vial dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Decitabine for Injection 50mg per vial are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — HAD2964A, Exp 7/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0582-2024.