The Recall Desk
HighFDA (Drugs)·D-1501-2020·Announced 2020-08-19

Eosera Recalls Ear Itch MD Sprays Due to Manufacturing Deviations

Eosera, Inc. is voluntarily recalling specific lots of Ear Itch MD sprays nationwide due to cGMP deviations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without specific reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported or is theoretically reversible.

Plain-English summary

Eosera, Inc. is voluntarily recalling 15,229 bottles of Day & Night Pack Ear Itch MD Anti-Itch Spray and Ear Itch MD Nighttime Intensive Soothing Spray. The products contain 1% pramoxine HCL and are sold in 0.5 FL OZ (15 mL) bottles. The recall was initiated on August 4, 2020, and was classified as Class II by the FDA.

The reason for the recall is cited as cGMP (Current Good Manufacturing Practice) deviations. The affected products were distributed nationwide within the United States. Specific lot numbers and expiration dates are TP203073 (Exp. SEP 21), TP203055 (Exp. OCT 21), and TP203012, TP203009, TP203006 (Exp. JUN 21).

The recall status is currently Terminated, with a termination date of September 10, 2021. Consumers should check their products for the listed lot numbers and expiration dates. The FDA classifies this as a Class II recall, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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
Manufacturer
Eosera, Inc.
Category
Drug — Topical OTC
Hazard
Affected units
15,229

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Eosera, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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