Eosera Day & Night Pack Ear Itch MD Anti-Itch Spray Recall

Why it was recalled

cGMP Deviations.

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

Lot numbers, UPCs & expiration codes

Lot #: TP203073 Exp. SEP 21; TP203055 Exp. OCT 21; TP203012, TP203009, TP203006 Exp. JUN 21

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-1501-2020
Classification: Class II
Status: Terminated
Recall initiated: Aug 4, 2020
FDA report date: Aug 19, 2020
Quantity: 15229 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Eosera, Inc.

Original FDA data

Every field from FDA enforcement report D-1501-2020, 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 #: TP203073 Exp. SEP 21; TP203055 Exp. OCT 21; TP203012, TP203009, TP203006 Exp. JUN 21
Postal code: 76115-3902
Report date: Aug 19, 2020
Product type: Drugs
Recall number: D-1501-2020
Classification: Class II
Recalling firm: Eosera, Inc.
Product quantity: 15229 bottles
Termination date: Sep 10, 2021
Reason for recall: cGMP Deviations.
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: Nationwide within the United States
Recall initiation date: Aug 4, 2020
Initial firm notification: Letter
Center classification date: Aug 13, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1501-2020, published Aug 19, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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