AmeriSource Bergen

FDA Regulatory Profile

AmeriSource Bergen appears in FDA public data with 2 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1066-2013, Class II) was initiated on September 13, 2013.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-1066-2013Class IIIfosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate September 13, 2013
D-1065-2013Class IIIfosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate September 13, 2013