Glass particles detected in recalled cancer treatment drug, FDA says

Doxorubicin Hydrochloride Liposome Injection, a cancer treatment drug,   was recalled after glass particles were detected in some of the vials. (Photo courtesy of the Food and Drug Administration)

Sun Pharma is voluntarily recalling a cancer treatment drug for the detection of glass particles in some vials during production. 

To date, the company has not received reports of adverse incidents related to the affected batch of the drug. Sun Pharma investigated the source of the issue and has taken preventive measures. 

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Food and Drug Administration officials stated in a May 13 release that if glass particles are administered through the veins, they may pose a serious risk to patient safety, including irritation or swelling in reaction to the foreign material. More severe risks might include blockage of blood vessels and life-threatening blood clot events.

Which cancer treatment drug is being recalled?

Why you should care:

Doxorubicin Hydrochloride Liposome Injection is the affected drug and a single batch of 675 vials were recalled due to the detection of glass particles in some vials during production. 

According to the Food and Drug Administration, Doxorubicin Hydrochloride Liposome Injection is used to treat ovarian cancer, AIDS related kaposi sarcoma and multiple myeloma. The single-dose vials have an expiration date of May 31, 2027.

If I have the recalled cancer drug, what should I do with it?

What you can do:

The Food and Drug Administration noted that Sun Pharma is informing its distributor and consumers by express overnight mail and is arranging for a return/replacement of all the recalled products.

Additionally, distributors, retailers, hospitals, and users that have the product should stop using it and return them to the place where the drug was purchased or throw the product away. 

Furthermore, consumers should call their physician or healthcare provider if they have experienced any issues that may be connected to taking or using this drug product. To report any adverse incidents, call NorthStar Rx LLC at 1-800-206-7821.

The Source: Information for this story was provided by a Food and Drug Administration recall letter. This story was reported from Washington, D.C.


 

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