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October 14, 2013 / Amanda Greenburg

FDA Says Several Over the Counter Ear Drops Are Mislabeled

The Food and Drug Administration (“FDA”) recently sent warning letters to the manufacturers of several homeopathic ear drop manufacturer ordering them to stop selling the products as over-the-counter (“OTC”) medications. The FDA is concerned about the following ear drops:

Manufacturer

Product Name

Homeolab USA Inc. Kids Relief Earache
Insight Pharmaceuticals Corp. Auro Earache Relief Ear Drops
Medtech Products Inc. Murine Ear Drops for Earache Relief
Topco Associates, LLC TopCare Earache Relief Ear Drops

In their letter, the FDA states the homeopathic ear drops labeling says their intended purpose is treat diseases that require a physician’s diagnosis.   Accordingly, these drops fall under the definition of a drug and must be dispensed by a prescription only.

OTC drugs may not be used for to treat illnesses that can only be diagnosed by a physician.  The FDA elaborated that OTC treatment for ear pain is also inappropriate as it may lead to serious injury if the condition is not evaluated by a physician.

If the manufacturers do not stop labeling these ear drops as OTC medications, they may face serious consequences.  It is within the FDA’s authority to seize the drugs if the drugs continue to hit the marketplace.   The FDA’s letter demands prompt corrective action to protect consumers.

The original blog posted on October 14, 2013 mistakenly listed TRP Company, Inc.’s Ring Relief Homeopathic Ear Drops and tablets as a company who received a letter from the FDA.   This statement was made in error.  I apologize for any confusion this error may have caused.

If you or someone you love has suffered harm from OTC ear drop medications, please contact Khorrami Boucher Sumner Sanguinetti, LLP for a private consultation.

 

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