Fusion Pharmaceuticals, LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-0410-2015Class IIDICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx OnMarch 6, 2015
D-1055-2014Class IIDicopanol FusePaq Kit for Oral Suspension, 5mg/MLMay 8, 2013