Irinotecan Hydrochloride Injection manufactured by APP Pharmaceuticals, Inc., a type of chemotherapy used to treat recurrent or progressive metastatic colorectal cancer, is being recalled because one lot of the drug was found to contain a fungal microbial contaminant. Non-sterility of a chemotherapeutic product administered intravenously can cause potentially deadly infections, especially in patients like these who have compromised immune systems.
Three customers have reported seeing foreign material in vials of Irinotecan Hydrochloride Injection. All reports were from vials in lot 870DE00301. Investigation confirmed that the particulate in the solution was a fungal microbial contaminant.
The recall includes lots 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. As a precautionary measure, recall involves lot 870DE00301, as well as those produced immediately before and after the affected lot.
APP has launched an investigation into the source of the contamination. The drug company says it is not aware of any adverse patient events resulting from the product, and that it is complying with the Food and Drug Administration (FDA).
Patients who have received Irinotecan Hydrochloride Injection therapy and experienced any problems should contact their physician. Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting Program at www. FDA.gov/MedWatch.