FDA-Drug2020-08-19Class II

Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5

Eosera, Inc.
Hazard

cGMP Deviations.

Sold states
Nationwide within the United States
Affected count
15229 bottles
Manufactured in
5000 South Fwy Ste 106, N/A, Fort Worth, TX, United States
Products
Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1501-2020

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