K-Y Moisturizer Recalled by FDA: What You Should Know (2024)

For menopausal women, the No. 1 complaint 10 years into it is vagin*l dryness. vagin*l dryness also affects millions of younger women as well. This month, J&J (Johnson and Johnson) was asked to recall more than 69,000 units of it's K-Y Liquibeads products after receiving more than 200 complaints from consumers between June 25, 2010 through Dec. 12, 2011. It seems the product is not dissolving or has an uncharacteristic consistency or texture.

A spokeswoman for the company said the recall wasn't unsafe and does not affect other types of K-Y vagin*l moisturizers. Consumers do not need to return any of the products.

"K-Y Liquibeads is being recalled from retailers and wholesalers to address the U.S Food and Drug Administration's concerns that the product should be cleared under a separate medical device application [called a 510k]," the company said in a statement earlier this month. "We are moving forward with the process to obtain clearance for the product."

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K-Y Liquibeads had been sold as part of an application for an existing K-Y product. The FDA determined that the Liquibead product needed a separate medical device application. At the time, McNeil (a subsidiary of J&J) said it would take whatever steps were necessary to address the FDA's concerns. This is all part of a larger manufacturing problem that J&J has been having.

So if you go to the drug store looking for Liquibeads and its no longer on the shelves, consider Replens. It offers women a safe, effective solution to vagin*l dryness and has received the FDA's 510(k) clearance, a requirement many companies have not met. Replens is estrogen free and long-lasting and has been clinically tested and shown to be as effective as vagin*l estrogen, about which so many health questions have been raised.

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K-Y Moisturizer Recalled by FDA: What You Should Know (2024)
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