Voluntary Recall of Irinotecan Announced

Web Exclusives - FDA Updates

APP Pharmaceuticals has issued a voluntary recall of 5 lots of irinotecan hydrochloride injection (Camptosar) as a precautionary measure. No adverse events related to the recalled products have been reported. The following lots have been recalled:

  • 870DE00301
  • 870CZ00301
  • 870DE00101
  • 870DE00201
  • 870DE00401

APP issued the recall after receiving customer complaints associated with lot 870DE00301, in which particulates were observed in the product solution. An investigation of the vials returned to the manufacturer established that the particulate matter was a fungal microbial contaminant. After consulting with the US Food and Drug Administration, and as a precautionary measure, all lots produced immediately before and after lot 870DE00301 are being recalled. For complete details, visit www.apppharma.com

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Last modified: July 22, 2021