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.