APP Pharmaceuticals has recalled five lots of Irinotecan Hydrochloride Injections used to treat colon cancer due to non-sterility issues that could cause serious injuries or death in patients whose immune systems are compromised. Three patients have already been affected due the discovery of foreign material which has been confirmed as a fungal microbial contaminant in the defective product lots.
An Irinotecan HCl Injection is used on patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
Raleigh, North Carolina-based APP Pharmaceuticals, Inc. has instituted an Irinotecan HCI Injection recall of 100mg/5mL, (20mg/mL), 5mL single dose vials and 40mg/2mL, (20mg/mL), 2mL single dose vials of the following lots:
Although only the first lot has been directly linked to injuries, APP Pharmaceuticals is recalling the additional batches listed - which were produced immediately before and after - as a safety precaution.
The U.S. Food & Drug Administration (FDA), which is working directly with the manufacturer, says that the company's mistake of creating a non-sterile chemotherapeutic product which is administered intravenously has the potential to result in infections and possibly be fatal - especially in patients who are already immuno-compromised.
The FDA and APP Pharmaceuticals are urging consumers to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. It's also important to keep in mind that the manufacturer may be liable for any injuries that consumers have experienced in the form of compensation for medical bills, lost wages and/or pain and suffering. You can determine if your family might be entitled to compensation by contacting an experienced products liability lawyer.