Fusion Pharmaceuticals, LLC

FDA Regulatory Profile

Fusion Pharmaceuticals, LLC appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0410-2015, Class II) was initiated on March 6, 2015.

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