Important Propofol Update!

For Immediate Release
November 17, 2009

FDA News on Propofol Injection Shortage

Dear Colleague,

As part of its efforts to resolve a critical shortage of propofol 1 percent injection products, FDA has authorized the importation of Fresenius Propoven 1 percent injection from the European Union, until such time that sources within the United States are capable of meeting local demand.  View the Propofol Importation Statement.

A Dear Healthcare Professional letter from APP Pharmaceuticals, A Company of the Fresenius Kabi Group, is being distributed with the product and will be posted on the FDA website; a copy of the letter is attached.

Updated information can be obtained at the following FDA website.

Healthcare professionals may report serious adverse events (side effects) concerning drug products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.  Please include the name of the product, the manufacturer, and lot number (if known).

Online:  MedWatch Online Voluntary Reporting Form (3500)
Regular Mail: Download postage-paid FDA Form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088
 

Sincerely,

Beth Fritsch, RPh, MBA
Office of Special Health Issues
Food and Drug Administration
Beth.Fritsch@fda.hhs.gov