Facebook Pixel

Non-Sterile Chemotherapy Injections Recalled

Rate This

APP Pharmaceuticals, Inc. is recalling five lots of the chemotherapy injection Irinotecan Hydrochloride which is given to patients with recurrent or metastatic colorectal cancer. The recall came after several medical staff complained that there were particulates in the injection solution. After APP had investigated three returned vials, they discovered that they contained a fungal microbial contaminant.

This is very dangerous as a non-sterile product given intravenously could cause severe infection and even death, especially in those who are immune-compromised. As colorectal cancer patients are already immune-compromised and dealing with a life threatening illness, they may not be able to fight off an acquired infection.

The affected lot numbers are 870DE00301, 870CZ00301, 870DE00101, 870DE00201 and 870DE00401of Irinotecan Hydrochloride Injection 100mg/5mL, (20mg/mL), 5mL Single Dose Vial and Irinotecan Hydrochloride Injection, 40mg/2mL, (20mg/mL), 2mL Single Dose Vial.

Health professionals should go to the APP website to read the "Dear Healthcare Professional" letter that details how to return the defective products, at http://www.apppharma.com

Patients who have been having chemotherapy who feel they have had a problem should discuss this with their doctor.

Adverse reactions or quality control problems associated with the product can be reported to the United States Food and Drug Administration online at:

Source: FDA

Add a CommentComments

There are no comments yet. Be the first one and get the conversation started!

Enter the characters shown in the image.
By submitting this form, you agree to EmpowHER's terms of service and privacy policy

We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.


Colon Cancer

Get Email Updates

Related Topics

Colon Cancer Guide


Have a question? We're here to help. Ask the Community.


Health Newsletter

Receive the latest and greatest in women's health and wellness from EmpowHER - for free!