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Press Release

Safety alert on an ear lubricant

17 July 2012

The Department of Health (DH) today (July 17) drew public attention to a voluntary recall of Oto-EaseĀ® ear lubricant manufactured by Westone Laboratories, Inc., in the United States (US) due to potential bacteria and mold contamination.

DH, through its routine surveillance on medical devices, noticed the above recall notice issued by the firm which was posted on the website of the US Food and Drug Administration (FDA). Acting on a customer complaint, FDA, through its sample analysis, found the product to be potentially contaminated with pathogenic bacteria and mold. Use of the product, which is intended for easing the insertion of hearing instruments, could result in infection of the ear canal and surrounding tissues. According to the manufacturer's information, no injuries or illness related to this product have been reported so far.

A DH spokesman said: "Consumers of the above product should stop using it immediately. They should consult their healthcare providers if they have used the product and feel unwell or if they are in doubt.

:According to the preliminary information on the FDA website, the products have been exported to various places outside the US, including Hong Kong. DH has immediately contacted the US manufacturer to verify the information, especially on whether the products have been distributed or sold in Hong Kong," he added.

The spokesman said DH had alerted the Hospital Authority, private hospitals, and medical professional associations to this recall notice.

So far, the department has not received any report of adverse events arising from this issue but shall monitor the development of the issue.

17 July 2012