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Oto-Ease® ear lubricant recalled due to bacterial contamination

Filed July 17th, 2012 Laurie

Westone Laboratories has decided to issue a recall on its Oto-Ease® ear lubricant because it may be contaminated with bacteria and mold.

According to a release from the company, the recall includes all sizes and packages of its Oto-Ease® ear lubricant. Westone decided to issue the recall after consumer complaints and testing conducted by the Food and Drug Administration determined it was contaminated with “pathogenic bacteria and mold.”

The Oto-Ease® ear lubricant is used in conjunction with devices that are inserted in the ear, such as ear molds and hearing aids. The product is designed to make inserting those devices easier but use of the affected Oto-Ease® ear lubricant could result in serious infections of the ear and ear canal.

Westone Laboratories issued a recall on this same product in October of last year without the knowledge of the FDA. Any customer with these products should stop using them immediately:

1) 0.5 oz semi transparent flexible plastic bottles with orange or semi transparent plastic screw-on dispensing caps; and
2) Aluminum foil single use sample packs with red or black print writing.

The Oto-Ease® ear lubricant product packages have no identifying marks, such as a product code, an expiration date, or a UPC code. There have been no reports of illness linked to the use of contaminated products.

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