FDA-Drug2013-02-13Class III
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
Bayer HealthCare Pharmaceuticals Inc.
Hazard
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Sold states
Nationwide
Affected count
138,505 vials
Manufactured in
2625 162nd St SW, N/A, Lynnwood, WA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-156-2013Don't want to check this manually?
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