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| The United States: Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Due To Potential Presence of Glass Particles (English only) |
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The US Food and Drug Administration (FDA) announces that Sun Pharmaceutical Industries, Inc. is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials). The single batch of 675 vials is being recalled due to the detection of glass particles in some vials during production.
If glass particles are administered intravenously, they may pose a risk to patient safety including local irritation or swelling in response to the foreign material. More serious potential risks could include blockage of blood vessels and life-threatening blood clot events. To date, Sun Pharma has not received any reports of adverse events related to this batch. Sun Pharma has thoroughly investigated the source of the problem and has taken corrective and preventative actions.
Doxorubicin Hydrochloride Liposome Injection is indicated for Ovarian cancer, AIDS Related Kaposi Sarcoma and Multiple Myeloma. The product is packaged in translucent, red liposomal dispersion in 25 mL glass, single-dose vials for NDC 72603-200-01. The affected DOXOrubicin Hydrochloride Liposome Injection batch is Batch HAG2581B, Expiration 05/31/2027. The product can be identified by the label (Aisling Label), each vial is labeled to indicate the name of the product: DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, NDC 72603-200-01 Lot# HAG2581B, Expiration 05/31/2027.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sun-pharmaceutical-industries-inc-sun-pharma-initiates-voluntary-us-nationwide-recall-doxorubicin
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, May 14, 2026
Issued at HKT 14:45
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