F. Hoffmann-LaRoche Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-105-2013Class IICymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 1September 5, 2012