Irinotecan Lots Recalled

APP Pharmaceuticals has voluntarily recalled five lots of irinotecan for injection.

Some customers discovered small particles of foreign material in one lot of the irinotecan vials.  Further inspection found fungal microbes in the vials they sent back.

It is unlikely that you as a patient would see the recalled vials or particles directly since irinotecan is diluted before your IV infusion.  However, you might develop an infection or other adverse event.  If that happens, call your doctor immediately!

The FDA and APP Pharmaceuticals tell patients

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.

The recalled lots are 870DE00301, 870CZ00301, 870DE00101, 870DE00201 and 870DE00401.

Irinotecan is used to treat metastatic colorectal cancer as alone or in combination with other chemotherapy in the FOLFIRI regimen.  It also is sometimes given with Erbitux® or Vectibix®.

APP has initiated this voluntary recall of Irinotecan Hydrochloride Injection to the retail level due to the discovery of foreign material and non-sterility in one lot of Irinotecan Hydrochloride 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. APP is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

FDA Safety Announcement.

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