Drug maker Cephalon, Inc., has issued a voluntary recall of an injectable medication to treat cancer because glass particulate fragments were found in one vial of the product.
The product being recalled is Treanda® for Injection 25 mg/8mL; lot TB30111, expiration date 12/2012. It is used to treat certain patients who have chronic lymphocytic leukemia or indolent B-cell non-Hodgkin’s lymphoma.
The company is recalling the product, it announced, because of potential safety and risk issues. Intravenous administration of solutions that contain particulates could cause emboli (blood clots that travel in the blood stream), the announcement said, that might disrupt blood flow and damage tissues and organs.
Those especially at risk are patients who are:
- Undergoing surgery
- Immunosuppressed
- Elderly
- Those with diseased blood vessels and have conditions such as heart and kidney disease
Cephalon said it has not been notified of any adverse events that could be caused by particulates in patients using the product.
The Treanda® lot being recalled is contained in 8 mL vials. It was distributed between March 22, 2011, and Oct. 5, 2011.
Patients who have questions about the recall may call 1-877-319-8965 between 9 a.m. and 5 p.m., CST, Monday through Friday. Distributors and wholesalers were notified of the recall by an overnight notification system on Nov. 18, 2011.
Source: FDA
If you or someone you love has been harmed by a recalled drug, contact Flood Law Group, LLP for help today at 1-202-756-1970.