The Recall Desk
ModerateFDA (Drugs)·D-1498-2020·Announced 2020-08-19

Eosera Recalls Ear Pain MD Pain Relief Drops For Kids

Eosera, Inc. is voluntarily recalling 45,673 bottles of Ear Pain MD Pain Relief Drops For Kids due to cGMP deviations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing deviation (cGMP) without reported adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Eosera, Inc. is voluntarily recalling 45,673 bottles of Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL). The recall was initiated on August 4, 2020, and is 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 72429-0070-8. Specific lot numbers and expiration dates involved in the recall include P203093 (Exp. DEC 21), P203026 (Exp. JUN 21), P193084 and P193044 (Exp. APR 21), P193073, P193072, P193071, and P193070 (Exp. FEB 21), P192050 (Exp. MAY 21), P193042 (Exp. MAR 21), P193013 (Exp. JAN 21), and P193012 (Exp. DEC 20). The product was distributed nationwide within the United States.

Consumers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact Eosera, Inc. for further instructions or a refund. The recall status is currently terminated.

The recalled product

Product
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
Manufacturer
Eosera, Inc.
Category
Drug — Ophthalmic/ENT
Hazard
Affected units
45,673

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 (13)

  • Lots: P203093 Exp. DEC 21
  • P203026 Exp. JUN 21
  • P193084
  • P193044
  • Exp. APR 21
  • P193073
  • P193072
  • P193071
  • P193070 Exp. FEB 21
  • P192050 Exp. MAY 21
  • P193042 Exp. MAR 21
  • P193013 Exp. JAN 21
  • P193012 Exp. DEC 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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