Bayer HealthCare Pharmaceuticals Inc. recalls Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, L
Recalled February 13, 2013 · FDA recall D-156-2013 · Bayer HealthCare Pharmaceuticals
Hazard
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point. · FDA Class III
Units
138,505 vials
Sold at
Nationwide
Description
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
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
Manufacturer(s)
Bayer HealthCare Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →