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Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant

Mon, 03/28/2011 - 6:37am
U.S. Food & Drug Administration

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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

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

    

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