Class II · Moderate risk Terminated
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only…
Reason cGMP deficiencies
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations.
What 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
- Recalling firm
- Eosera, Inc.
- NDC code
- 72429-0071-5
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1500-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Pramoxine recalls
See all
Class II · Moderate risk Terminated
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk 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…
Reason cGMP Deviations.
Class III · Low risk Terminated
Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC…
Reason Subpotent Drug: Out of specification result for pramoxine hydrochloride
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