July 17, 2012
Westone Laboratories Inc. Recalls Oto-Ease® Ear Lubricant
The Missouri Department of Health and Senior Services received the following news release regarding the recall of all sizes and packaging configurations of Oto-Ease® ear lubricant due to the potential contamination of pathogenic bacteria and mold. Use of the product as directed for easing the insertion of custom fit ear molds and hearing instruments (including hearing aids) could result in infectious complications of the ear canal and surrounding tissues.
This product was previously recalled in October 2011 within the United States and from Australia. Consumers who have any size or packaging configuration should stop using the product and contact their healthcare provider. Packaging configurations include the following:
- 0.5 oz semi transparent flexible plastic bottles with orange or semi transparent plastic screw-on dispensing caps; and
- Aluminum foil single use sample packs with red or black print writing.
The Oto-Ease unit containers are not identified with a lot number, expiration date, or UPC Code.
The products were distributed to hospitals, health professionals, and retailers nationwide.
The full recall can be found at www.fda.gov/Safety/Recalls/ucm311978.htm?source=govdelivery.