Class II · Moderate risk
Proctofoam HC
cGMP deficiencies
Day & Night Pack Ear Itch MD Anti-Itch Spray
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What 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
Affected NDC
72429-0071-05
Compare with the code on your package — it is the most precise check available.
Drug: Pramoxine
- Recalling firm
- Eosera, Inc.
- NDC code
- 72429-0071-5
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1501-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Pramoxine recalls
See all
Class II · Moderate risk
Proctofoam HC
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ear Itch MD Anti-Itch Spray
cGMP Deviations.
Class III · Low risk
Novacort Gel Sample Packets
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Other recalls by Eosera, Inc.
All 2020 recalls
Class II · Moderate risk
Ear Itch MD Anti-Itch Spray
cGMP Deviations.
Class II · Moderate risk
Ear Pain MD Pain Relief Drops with 4% Lidocaine
cGMP Deviations.
Class II · Moderate risk
Ear Pain MD Pain Relief Drops For Kids
cGMP Deviations.
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