Westone Laboratories has voluntarily recalled all sizes and packaging configurations of Oto-Ease ear lubricant that was shipped after September 1, 2011. Packaging configurations include 0.5 oz semi-transparent flexible plastic bottles with either the orange or semi-transparent plastic screw-on dispensing caps, as well as the aluminum foil single-use sample packs with either black or red writing.
A consumer complaint and U.S. Food and Drug Administration sample analysis indicated that the material was potentially contaminated, the operative word being “potentially“. The recall was not a mandate; rather, it was a voluntary recall that Westone elected to ensue in the best interest of its customers. It is important to note that there have been no reports or complaints of injuries and/or illnesses from the use of Oto-Ease.
Westone has temporarily suspended the sale of Oto-Ease as the company continues to conduct its own independent tests to ascertain the nature and extent of any potential contamination. The company is asking hearing health care providers to inspect inventory and either destroy or send any unused product back. If the product was further distributed to patients, Westone is asking that hearing health care providers contact their patients to notify them of the product recall. Consumers with questions can contact Westone Laboratories at 1-800-357-3240 between 8:00 am and 5:00 Mountain Standard Time or e-mail at otoeaserecall@westone.com.
