Why K-Y Liquibeads Vaginal Moisturizer Was Recalled

Why K-Y Liquibeads Vaginal Moisturizer Was Recalled

by Dr. Mache Seibel

Ten years into menopause, vaginal dryness is the number one complaint. And it affects  millions of younger women as well. Earlier this month, J&J (Johnson and  Johnson) was asked to recall over 69,000 units of its K-Y Liquibeads products  after receiving over 200 complaints from consumers between June 25, 2010  and Dec. 12, 2011. It seems the product is not dissolving and/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 vaginal 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,” the company said in a  statement earlier this month. “We are moving forward with the process to obtain  clearance for the product.”

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 JNJ) said it would take  whatever steps were necessary to address FDA’s concerns. This is all part of a  larger manufacturing problem that J&J has been  having.

So if you go to the drugstore looking for Liquibeads and it’s no longer on  the shelves, consider Replens.  It offers women a safe, effective solution to vaginal 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 vaginal estrogen, about which so many health questions have  been raised.