Oto-Ease Ear Lubricant is being recalled for potential bacterial and mold contamination, the U.S. Food & Drug Administration (FDA) just announced.
Westone Laboratories, Inc. initiated the nationwide recall for all sizes and packaging configurations of its Oto-Ease® ear lubricant. Through a consumer complaint and agency analysis, Oto-Ease Ear Lubricant products were found to be potentially contaminated with pathogenic bacteria and mold. Use of Oto-Ease—as directed for easing the insertion of custom fit ear molds and hearing instruments, including hearing aids—could cause infectious complications of the ear canal and surrounding tissues.
In fact, Oto Ease Ear Lubricant was recalled previously, in October 2011, within the United States and from Australia, all without FDA knowledge, the agency said.
The FDA advises consumers in possession of any size or packaging configuration of Oto Ease Ear Lubricant to stop using the product and contact their healthcare provider. Packaging configurations include:
• 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.
No injuries or illnesses have been reported, to date, in connection to this recall, which is being conducted with the full knowledge of the FDA.
Westone Laboratories said it is notifying its distributors and customers through direct letter, and is arranging for the disposal or return of all recalled products. The firm can be reached, toll-free, at 1.800.357.3240, between 8:00 a.m. and 5:00 p.m., Mountain Standard Time (MST), or by email to email@example.com.
The recall Oto-Ease Ear Lubricant products were distributed to hospitals, health professionals, and retailers nationwide and to Belgium, Greece, Canada, Thailand, Australia, Panama, Singapore, the Russian Federation, Ireland, the Philippines, France, Korea, the United Kingdom, Switzerland, Brazil, Japan, Germany, Mexico, Hong Kong, and Sweden.
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Events Program either online, by regular mail or by fax: Online at www.fda.gov/medwatch/report.htm; by regular mail, use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm; or by toll-free fax to 1.800.FDA.0178.