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
Reported: February 13, 2013 Initiated: May 31, 2012 #D-156-2013
Product Description
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.
Details
- Recalling Firm
- Bayer HealthCare Pharmaceuticals Inc.
- Units Affected
- 138,505 vials
- Distribution
- Nationwide
- Location
- Lynnwood, WA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Bayer HealthCare Pharmaceuticals Inc.. Units affected: 138,505 vials.
Why was this product recalled? ▼
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 13, 2013. Severity: Low. Recall number: D-156-2013.
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