Reported Feb 13, 2013 · Terminated
Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals,…
Bayer HealthCare Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer HealthCare Pharmaceuticals Inc. · 2625 162nd St SW · Lynnwood, WA · 98087
Is this the product you have?
- Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only
- Mfd byBayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2
- Lot codes and dates
B18511 Exp. 04/12B18513 Exp. 05/12B18515 Exp. 06/12B18517 Exp. 06/12B18825 Exp. 10/12B18831 Exp.12/12
- Amount recalled
- 138,505 vials
Where it was sold
- Nationwide
Why it was recalled
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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