February 24, 2012
Bedford Laboratories voluntarily recalled specific lots of cytarabine1 gram injection due to questions of sterility found through investigations of the manufacturing site after the product was released. No adverse effects linked to this recall have been reported at this time. The three recalled lot numbers are listed below.
Cytarabine 1 gram (NDC 55390-0133-01) vials
- Lot #: 2066986
- Lot #: 2111675
- Lot #: 2131148
Bedford advises healthcare facilities and providers to not use these products. Quarantine and return all affected products. Contact Bedford Laboratories Client Services (1-800-562-4797) with any questions regarding this recall. Contact Bedford Laboratories Professional Services Department (1-800-521-5169) 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:
February 24, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.