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irinotecan FDA Alerts

The FDA Alert(s) below may be specifically about irinotecan or relate to a group or class of drugs which include irinotecan.

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for irinotecan

Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant

Mar 28, 2011

Audience: Oncology, Pharmacy, Risk Manager

ISSUE: APP Pharmaceuticals, Inc. issued a voluntary recall of five lots of Irinotecan Hydrochloride Injection due to the discovery of foreign material and non-sterility in one lot of Irinotecan injection. Non-sterility of a chemotherapeutic product administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.

BACKGROUND: Irinotecan Hydrochloride Injection is used for recurrent or progressive metastatic colorectal cancer. Three customers reported that they discovered a particulate in the product solution in lot 870DE00301. Investigation of the returned vials confirmed that the particulate was a fungal microbial contaminant. See the Firm Press Release for a listing of recalled lot numbers.

RECOMMENDATION: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[03/25/2011 - Press Release - APP Pharmaceuticals]


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