Sun Pharma Recalls Doxorubicin Liposome Injection Due to Glass Particle Contamination
核心洞察
Sun Pharma voluntarily recalled a single batch of 675 vials of Doxorubicin Hydrochloride Liposome Injection after detecting glass particles during production.
The FDA warns that glass particles administered intravenously pose serious safety risks including blood vessel blockage and life-threatening blood clot events.
The recalled cancer treatment drug is used for ovarian cancer (搜索), AIDS-related Kaposi sarcoma (搜索), and multiple myeloma (搜索) with an expiration date of May 31, 2027.
Sun Pharma has voluntarily recalled a batch of Doxorubicin Hydrochloride Liposome Injection after detecting glass particles in some vials during production, the Food and Drug Administration (搜索) announced on May 13. The recall affects 675 single-dose vials with an expiration date of May 31, 2027.
Safety Concerns and Risks
The FDA emphasized the serious safety risks associated with glass particle contamination in injectable medications. If glass particles are administered through the veins, they may cause irritation or swelling in reaction to the foreign material. More severe complications include blockage of blood vessels and life-threatening blood clot events.
Affected Drug and Indications
Doxorubicin Hydrochloride Liposome Injection is used to treat multiple cancer types, including ovarian cancer (搜索), AIDS-related Kaposi sarcoma (搜索), and multiple myeloma (搜索). The contamination was discovered during the production process, prompting the immediate voluntary recall.
Company Response and Investigation
Sun Pharma investigated the source of the contamination issue and has implemented preventive measures to prevent future occurrences. To date, the company has not received reports of adverse incidents related to the affected batch of the drug.
Recall Process and Patient Actions
The FDA noted that Sun Pharma is informing its distributors and consumers through express overnight mail and is arranging for return and replacement of all recalled products. Healthcare facilities, distributors, retailers, and users who have the product should immediately stop using it and return the vials to the place of purchase or dispose of them properly.
Patients who have experienced any issues that may be connected to taking or using this drug product should contact their physician or healthcare provider immediately. Adverse incidents can be reported to NorthStar Rx LLC at 1-800-206-7821.