Irinotecan Hydrochloride Injection Recall Issued by APP Pharmaceuticals

Five lots of Irinotecan Hydrochloride injection, a colon cancer drug, have been recalled after fungus was found floating in some vials.

The Irinotecan Hydrochloride injection recall was announced on March 25 by the FDA and APP Pharmaceuticals, the manufacturer, after three customers reported that they saw particles of foreign material floating in the vials. When the vials were analyzed by APP it was discovered that the material was a fungal microbial contaminant.

Non-sterility or foreign material in chemotherapy products could cause infections, and in some cases could be fatal if injected into a cancer patient whose immune system has been compromised by chemotherapeutic treatments. However, there have been no reports of illness or death in connection to the recalled colon cancer treatment injections.

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The recall affects five lots of Irinotecan Hydrochloride Injection, 100mg/5mL, (20mg/mL), 5mL Single Dose Vial and Irinotecan Hydrochloride Injection, 40mg/2mL, (20mg/mL), 2mL Single Dose Vial. The lot numbers affected by the recall include 870DE00301, 870CZ00301, 870DE00101, 870DE00201 and 870DE00401. Only vials from lot 870DE00301 have been confirmed as being contaminated, but the company says it expanded the recall to include lots produced immediately before and after that one at the urging of the FDA out of an abundance of caution.

Irinotecan Hydrochloride injection is approved by the FDA for the treatment of patients suffering from colorectal cancer that has either recurred or failed to respond initial therapy. One side effect of Irinotecan Hydrochloride is that it can lower the number of white blood cells in a patient’s body, due to bone marrow depression. This can cause the patient to become more susceptible to infections.

APP Pharmaceuticals sent out a Dear Healthcare Professional letter (pdf) on March 22 informing healthcare providers of the problem. The fungus was sent out to two genetics testing laboratories but has, so far, not been identified.


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