APP Pharmaceuticals, Inc. is recalling five lots of the chemotherapy injection Irinotecan Hydrochloride which is given to patients with recurrent or metastatic colorectal cancer. The recall came after several medical staff complained that there were particulates in the injection solution. After APP had investigated three returned vials, they discovered that they contained a fungal microbial contaminant.
This is very dangerous as a non-sterile product given intravenously could cause severe infection and even death, especially in those who are immune-compromised. As colorectal cancer patients are already immune-compromised and dealing with a life threatening illness, they may not be able to fight off an acquired infection.
The affected lot numbers are 870DE00301, 870CZ00301, 870DE00101, 870DE00201 and 870DE00401of Irinotecan Hydrochloride Injection 100mg/5mL, (20mg/mL), 5mL Single Dose Vial and Irinotecan Hydrochloride Injection, 40mg/2mL, (20mg/mL), 2mL Single Dose Vial.
Health professionals should go to the APP website to read the "Dear Healthcare Professional" letter that details how to return the defective products, at http://www.apppharma.com
Patients who have been having chemotherapy who feel they have had a problem should discuss this with their doctor.
Adverse reactions or quality control problems associated with the product can be reported to the United States Food and Drug Administration online at:
www.fda.gov/medwatch/report.htm
Source: FDA