Health Alert: Unapproved Prescription Ear drop in Circulation

In an era were people have become so gullible and are very desperate to be rich in expense of fellow citizens especially in a country such as ours.

There is a growing concern for approved health equipment, drugs and other health care products. It is often easier for these desperate entities to maneuver their way through the Custom checks and bring in unapproved products into the country. One of such cases is the unapproved EAR DROP PRODUCT known as OTIC  labelled to relieve ear pain, infection, and inflammation.

unapproved otic ear drop product
unapproved otic ear drop product

The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone and have not been evaluated by Food and Drug Administration (FDA) for safety, effectiveness, and quality. The labels on these products do not disclose that they lack FDA approval, and health professionals may not be aware of their unapproved status. Consequently FDA has announced its intention to take enforcement action against companies that manufacture and/or distribute these unapproved products.

Unapproved prescription otic drug products containing the following ingredients are covered by this action:

  • benzocaine;
  • benzocaine and antipyrine;
  • benzocaine, antipyrine, and zinc acetate;
  • benzocaine, chloroxylenol, and hydrocortisone;
  • chloroxylenol and pramoxine; and
  • chloroxylenol, pramoxine, and hydrocortisone.

Young children and patients having ear infections and other conditions that cause ear pain and swelling are frequently given these unapproved prescription otic drug products and may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labelled directions for use.

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In view of this development action is required on our path, as well as the patients who believe they are using unapproved prescription ear drops to contact their health care provider to discuss alternatives.

And any health professional prescribing such and unapproved product should desist from it and Notify the Agency immediately of any such products for further necessary actions.

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