June 16, 2011
RECALL: Bedford Labs Recalls Indomethacin for InjectionBedford Laboratories has initiated a nationwide voluntary recall of one lot of indomethacin for injection 1mg single-dose vials because it may contain particulate matter. The particulate matter has been identified as active drug substance and not foreign material or contamination. The lot being recalled is NDC# 55390-299-01, Lot 1948138, Exp. Date September 2011. Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use Bedford Laboratories' indomethacin for injection Lot 1948138 for patient care and should immediately quarantine any product for return.
Indomethacin for injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants, who typically have small blood vessels.
For more information call (800) 562-4797 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259262.htm.