PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 19, 2020 Initiated: August 4, 2020 #D-1500-2020

Product Description

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

Reason for Recall

cGMP Deviations.

Details

Recalling Firm
Eosera, Inc.
Units Affected
43,424 bottles
Distribution
Nationwide within the United States
Location
Fort Worth, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Eosera, Inc.. Units affected: 43,424 bottles.
Why was this product recalled?
cGMP Deviations.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 19, 2020. Severity: Moderate. Recall number: D-1500-2020.