Eosera, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-1500-2020Class IIEar Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South FrAugust 4, 2020
D-1501-2020Class IIDay & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch August 4, 2020
D-1499-2020Class IIEar Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) botAugust 4, 2020
D-1498-2020Class IIEar Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, EosAugust 4, 2020