APP Pharmaceuticals, Inc., announced that it has issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection, which is used for recurrent or progressive metastatic colorectal cancer. This recall is being conducted as a precautionary measure and there have been no reports to date of adverse events related to the recalled products. APP has voluntarily recalled 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. APP decided to take this action due to an atypical trend in customer complaints associated with lot 870DE00301. Three customers reported that they discovered a particulate in the product solution in lot 870DE00301. Upon further investigation of the returned vials, the particulate was confirmed to be a fungal microbial contaminant.
APP’s root cause investigation is ongoing; however, APP’s preliminary investigation indicates that only products from lot 870DE00301 were involved. As a precautionary measure and in consultation with the U.S. Food and Drug Administration the lots produced immediately before and after lot 870DE00301 are also being recalled.