APP Pharmaceuticals has issued a voluntary recall of five lots of irinotecan HCl injection due to the discovery of foreign particulate material and nonsterility in one lot. The following lots of irinotecan HCl injection 20mg/mL in 2mL and 5mL single-dose vials are being recalled: 870DE00301, 870CZ00301, 870DE00101, 870DE00201 and 870DE00401. Patients should contact their healthcare provider if they experience any adverse effects they feel may be related to the use of these products.
Irinotecan injection is indicated for the treatment of recurrent or progressive metastatic colorectal cancer.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248598.htm.