Status
Terminated
Drug Enforcement D-156-2013
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Classification
Class III
Report Date
February 13, 2013
Termination Date
May 10, 2013
Product Information
- 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
- Product quantity
- 138,505 vials
- Reason for recall
- Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Address
-
2625 162nd St SW, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-156-2013
- Event ID
- 62908
- Recall initiation date
- May 31, 2012
- Center classification date
- February 7, 2013
- 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
- More code info
- —