FDA recall D-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

Reason for recall

Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-05-31

Report date

2013-02-13

Termination date

2013-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lynnwood, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-156-2013