Product: Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
Reason for recall: Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Recall initiated: 20120531
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated