Polymyxin B and Vecuronium
January 12, 2012
Bedford Laboratories voluntarily recalled specific lots of polymyxin B and vecuronium because visible glass particles were present in some vials. Serious adverse events or death are possible if particulate matter is injected intravenously, intrathecally, or subconjunctivally. The affected products with corresponding lot numbers are listed below.
Polymyxin B for injection
- 500,000 units vial, NDC55390-0139-10
- Lot 1942980, Expiration: August 2013
- Lot 1895027, Expiration: June 2013.
Vecuronium bromide for injection
- 10 mg vial, NDC 55390-0037-10
- Lot 1865067, Expiration: May 2012
- 20 mg vial, NDC 55390-0039-10
- Lot 1865069, Expiration: February 2012
Bedford initially notified wholesalers and distributors of this recall and arranged for product returns on August 2, 2011. Bedford advises that healthcare facilities not use these products. Quarantine and return all affected products. Contact Bedford Laboratories Professional Services Department (1-800-521-5169) with any questions regarding this recall or to report adverse events associated with the use of affected product. Adverse events may also be reported to FDA’s MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm).
Additional information is available at the following links:
- FDA MedWatch Alert:
- Bedford Laboratories Release with list of recalled products:
January 12, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.