Propofol (Hospira) - Recall of Additional Lots Due to Presence of Particulate Matter - UPDATE
June 11, 2010
Hospira initiated a voluntary recall of additional lots of propofol injection. Lot numbers beginning with 66-78 and 82-85 are affected. Lot numbers beginning with 79 and 80 remain affected by the recall. All lot numbers were distributed from March 2008 to April 2010. The particulate matter appears to have originated from the stainless steel equipment used during manufacturing. Adverse events due to the presence of particulate matter have not been reported. However, there is the concern that the foreign particulate matter may cause serious adverse effects including restricted blood flow in the body and embolism. Do not use propofol from these affected lot numbers and quarantine the product. Return product from these lot numbers to Stericycle (866-654-0725). Report any adverse events to FDA online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mailing the completed form. The MedWatch form is available at http://www.fda.gov/downloads/Safety/MedWatch/DownloadForms/UCM082725.pdf.
Additional information may be found at the following links:
- Press Release:
June 11, 2010; November 11, 2009; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.