PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 19, 2020 Initiated: August 4, 2020 #D-1501-2020

Product Description

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

Reason for Recall

cGMP Deviations.

Details

Recalling Firm
Eosera, Inc.
Units Affected
15229 bottles
Distribution
Nationwide within the United States
Location
Fort Worth, TX

Frequently Asked Questions

What product 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. Recalled by Eosera, Inc.. Units affected: 15229 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-1501-2020.