The Recall Desk
HighFDA (Drugs)·D-1500-2020·Announced 2020-08-19

Eosera Recalls Ear Itch MD Anti-Itch Spray Due to cGMP Deviations

Eosera, Inc. is voluntarily recalling 43,424 bottles of Ear Itch MD Anti-Itch Spray due to cGMP deviations. The product was distributed nationwide in the United States.

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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text cites cGMP deviations but does not report specific illnesses or injuries, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Eosera, Inc. is voluntarily recalling 43,424 bottles of Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL). 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 product is identified by NDC 72429-0071-5 and UPC 851722007125. The recall includes multiple lot numbers with expiration dates ranging from August 2020 to October 2021. Specifically, the lots include F203071, F203059, F193095, F193094, F193093, F193082, F193069, F193061, F193058, F193054, F193032, F193030, F193029, F193028, F193027, F193026, F193025, and F193024.

The product was distributed nationwide within the United States. The recall status is currently terminated as of September 10, 2021. Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, consumers should stop using it and follow the firm's instructions for return or disposal, as the recall was initiated by the firm via letter notification.

The recalled product

Product
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
Manufacturer
Eosera, Inc.
Category
Drug — Topical Ophthalmic/Ear
Hazard
Affected units
43,424

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 (18)

  • 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

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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