FDAFDA · Food and drugs·Recall number D-156-2013
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
Published February 13, 2013 · Recall initiated: May 31, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bayer HealthCare Pharmaceuticals Inc.
- Distributor
- Nationwide
- Lot
- B18511 Exp. 04/12 , B18513 Exp. 05/12, B18515 Exp. 06/12, B18517 Exp. 06/12, B18825 Exp. 10/12, B18831 Exp.12/12
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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