Recalls / Class III
Class IIID-156-2013
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
- Affected lot / code info
- B18511 Exp. 04/12 , B18513 Exp. 05/12, B18515 Exp. 06/12, B18517 Exp. 06/12, B18825 Exp. 10/12, B18831 Exp.12/12
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.
Recalling firm
- Firm
- Bayer HealthCare Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2625 162nd St SW, N/A, Lynnwood, Washington 98087
Distribution
- Quantity
- 138,505 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-05-31
- FDA classified
- 2013-02-07
- Posted by FDA
- 2013-02-13
- Terminated
- 2013-05-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-156-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.