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Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant
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.
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