No injuries or illnesses have been reported to date
Westone Laboratories has recalled of all sizes and packaging configurations of Oto-Ease® ear lubricant. A U.S. Food and Drug Administration (FDA) sample analysis found the product 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.
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.
No injuries or illnesses have been reported to date.
Any adverse events that may be related to the use of the affected products should be reported to the FDA's MedWatch Adverse Event Reporting program. The report may be made by phone at 1-800-FDA-1088, online at www.fda.gov/MedWatch/report.htm, or by returning the postage paid FDA form 3500. The form may be downloaded from www.fda.gov/MedWatch/getforms.htm and mailed to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or faxed to 1-800-FDA- 0178.
The Monterey County Health Department releases notices of recalls and market withdrawal from the firms involved as a service to Monterey County residents, the media and other interested parties. The Health Department does not endorse either the product or the company.