Why it was recalled
cGMP Deviations.
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
Lot numbers, UPCs & expiration codes
Lot #: F203071 Exp. SEP 21; F203059 Exp. OCT 21; F193095, F193094 Exp. MAY 21; F193093 Exp. APR 21; F193082 Exp. MAR 21; F193069 Exp. FEB 21; F193061 Exp. JAN 21; F193058, F193054 Exp. DEC 20; F193032, F193030, F193029, F193028, F193027, F193026, F193025, F193024 Exp. AUG 20
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1500-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 4, 2020
- FDA report date
- Aug 19, 2020
- Quantity
- 43,424 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eosera, Inc.
Original FDA data
Every field from FDA enforcement report D-1500-2020, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 86171
- Address
- 5000 South Fwy Ste 106
- Code information
- Lot #: F203071 Exp. SEP 21; F203059 Exp. OCT 21; F193095, F193094 Exp. MAY 21; F193093 Exp. APR 21; F193082 Exp. MAR 21; F193069 Exp. FEB 21; F193061 Exp. JAN 21; F193058, F193054 Exp. DEC 20; F193032, F193030, F193029, F193028, F193027, F193026, F193025, F193024 Exp. AUG 20
- Postal code
- 76115-3902
- Report date
- Aug 19, 2020
- Product type
- Drugs
- Recall number
- D-1500-2020
- Classification
- Class II
- Recalling firm
- Eosera, Inc.
- Product quantity
- 43,424 bottles
- Termination date
- Sep 10, 2021
- Reason for recall
- cGMP Deviations.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 4, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 13, 2020