Missouriwatcher
Editor, Senior Moderator
July 13,2012, Westone Laboratories, Inc. is initiating a voluntary nationwide recall of all sizes and packaging configurations of Oto-Ease? ear lubricant. The products have been found through a consumer complaint and the U.S. Food and Drug Administration (FDA) sample analysis to be potentially contaminated with 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 (without FDA knowledge).
Consumers who have any size or packaging configuration should stop using the product and contact their healthcare provider. Packaging configurations include the following:
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 unit containers are not identified with a lot number, expiration date, or UPC Code.
No injuries or illnesses have been reported to date. This recall is being conducted with the full knowledge of the FDA...
The products were distributed to hospitals, health professionals, and retailers nationwide and to Belgium, Greece, Canada, Thailand, Australia, Panama, Singapore, Russian Federation, Ireland, The Philippines, France, Korea, United Kingdom, Switzerland, Brazil, Japan, Germany, Mexico, Hong Kong, Sweden.
http://www.fda.gov/Safety/Recalls/ucm311978.htm
This product was previously recalled in October 2011 within the United States and from Australia (without FDA knowledge).
Consumers who have any size or packaging configuration should stop using the product and contact their healthcare provider. Packaging configurations include the following:
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 unit containers are not identified with a lot number, expiration date, or UPC Code.
No injuries or illnesses have been reported to date. This recall is being conducted with the full knowledge of the FDA...
The products were distributed to hospitals, health professionals, and retailers nationwide and to Belgium, Greece, Canada, Thailand, Australia, Panama, Singapore, Russian Federation, Ireland, The Philippines, France, Korea, United Kingdom, Switzerland, Brazil, Japan, Germany, Mexico, Hong Kong, Sweden.
http://www.fda.gov/Safety/Recalls/ucm311978.htm