Westone Laboratories, Inc. has announced the recall of all sizes and packaging configurations of Oto-Ease® ear lubricant due to its potential contamination of pathogenic bacteria and mold.
Oto-Ease is an ear lubricant used for easing the insertion of custom ear molds and hearing aids.
Although no injuries or illnesses have yet been reported, the recalled product could potentially cause infectious complications to the ear canal and surrounding tissue.
Without FDA knowledge, the product was recalled in October 2011 in the United States and Australia. However, the FDA has full knowledge of the current recall.
Affected packaging includes a 0.5 oz transparent bottles with orange or semi transparent plastic dispensing caps, and aluminum foil sample packs with red or black print.
According to a statement from the FDA the affected products were distributed to hospitals, health professionals, and retailers in the United States, Belgium, Greece, Canada, Thailand, Australia, Panama, Singapore, Russian Federation, Ireland, The Philippines, France, Korea, United Kingdom, Switzerland, Brazil, Japan, Germany, Mexico, Hong Kong, and Sweden.
“EMSL Analytical routinely detects mold and bacterial contamination in personal care products in our FDA-registered laboratory in Cinnaminson, NJ,” states Diane Miskowski, MPH, Business Development Manager at EMSL Analytical. “Our laboratory boasts the most cutting-edge instrumentation and is cGMP and ISO 17025 compliant.”
About EMSL Analytical, Inc.
EMSL Analytical is a full service testing company providing quality lab services under the same private ownership since 1981. Including the corporate lab facility in Cinnaminson, NJ, EMSL Analytical operates over thirty laboratories nationwide in the US and Canada. We provide analytical services for environmental, indoor air quality (IAQ), industrial hygiene, forensics and materials science, consumer products, food safety, PCR, pharmaceutical, asbestos, lead, and radiological samples. The company has an extensive list of accreditations from leading organizations, as well as state and federal regulating bodies. Please see our website for a complete listing of accreditations.