Pharmacy Services

Irinotecan Hydrochloride Injection

March 28, 2011

APP Pharmaceuticals is voluntarily recalling multiple lots of irinotecan hydrochloride injection. Fungal particulates were confirmed by 3 separate reports involving the lot number 870DE00201. Other lots are being recalled as a precautionary measure. Solutions containing particulates may pose a safety risk if administered to patients. No adverse events have been reported as a result of these contaminants. The following lots of irinotecan vials are affected by this recall:

Irinotecan 100 mg/5 mL, single-use vial

  • Lot # 870DE00201
  • Lot # 870DE00101
  • Lot # 870DE00201
  • Lot # 870DE00401

Irinotecan 40 mg/2 mL, single-use vial

  • Lot # 870CZ00301

Immediately quarantine and avoid administering the affected product. Please contact APP at 1-866-716-2459 for further details on returning product. Report any adverse events to the FDA MedWatch program. Additional information is available at the following link: