irinotecan FDA Alerts
The FDA Alert(s) below may be specifically about irinotecan or relate to a group or class of drugs which include irinotecan.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for irinotecan
Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant
Mar 28, 2011
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]
More irinotecan Resources
- Irinotecan Consumer Information
- Irinotecan (Conventional) Consumer Information
- Novaplus Irinotecan Hydrochloride Advanced Consumer Information
- Irinotecan Intravenous Advanced Consumer Information
- Irinotecan Hydrochloride AHFS DI Monograph
- Irinotecan Prescribing Information
- Onivyde Prescribing Information
- Irinotecan (Conventional) A-Z Drug Facts