FDA recall D-1500-2020
Eosera, Inc. · Class II · drug
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
Reason for recall
cGMP Deviations.
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2020-08-04
- Report date
- 2020-08-19
- Termination date
- 2021-09-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Fort Worth, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1500-2020