Day & Night Pack Ear Itch MD Anti-Itch Spray recalled over manufacturing violations

Recall date

August 4, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Eosera, Inc. recalls Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intens…

Recall number

D-1501-2020

FDA classification

Class II

Brand / firm

Eosera, Inc.

Sold / distributed

Nationwide within the United States

Why it was recalled

cGMP Deviations.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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