Asclemed USA Inc. dba Enovachem

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-0354-2019Class IDyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals,December 11, 2018
D-0353-2019Class IDyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals,December 11, 2018