Ear Itch MD Spray (Eosera) – manufacturing deviation (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125
Brand
Eosera, Inc.
Lot Codes / Batch Numbers
Lot #: F203071 Exp. SEP 21, F203059 Exp. OCT 21, F193095, F193094 Exp. MAY 21, F193093 Exp. APR 21, F193082 Exp. MAR 21, F193069 Exp. FEB 21, F193061 Exp. JAN 21, F193058, F193054 Exp. DEC 20, F193032, F193030, F193029, F193028, F193027, F193026, F193025, F193024 Exp. AUG 20
Products Sold
Lot #: F203071 Exp. SEP 21; F203059 Exp. OCT 21; F193095, F193094 Exp. MAY 21; F193093 Exp. APR 21; F193082 Exp. MAR 21; F193069 Exp. FEB 21; F193061 Exp. JAN 21; F193058, F193054 Exp. DEC 20; F193032, F193030, F193029, F193028, F193027, F193026, F193025, F193024 Exp. AUG 20
Eosera, Inc. is recalling Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Fr due to cGMP Deviations.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP Deviations.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026