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SUN PHARMACEUTICAL INDUSTRIES INC — Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
The 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.
Details
- Units affected
- 2088 vials
- Recall date
- July 2, 2024
- Brand
- SUN PHARMACEUTICAL INDUSTRIES INC
Nationwide in the USA
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “SUN PHARMACEUTICAL INDUSTRIES INC — 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, Manufact”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine