Johnson and Johnson is recalling K-Y brand Liquibeads vaginal moisturizer that must be cleared with the U.S. Food and Drug Administration (FDA) under a new application before being sold again.
The 69,000 units of Liquibeads affected were sold nationwide and are already being pulled from shelves. Johnson and Johnson stresses that there are no safety or product issues with the Liquibeads, and that the company is in the process of getting â€œclearanceâ€ for the product under a new medical device application.
Nasdaq reports that â€œK-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.â€
Last May, FDA sent McNeil PPC, the division of Johnson and Johnson that manufactures K-Y products, a warning letter listing the following:
227 K-Y Liquibeads Vaginal Moisturizer complaints from June 25, 2010 through December 12, 2011.
68 of these complaints were classified as medical complaints and were not adequately evaluated and investigated, according to the letter.
Some of the complaints said the product “Does Not Dissolve” and/or has an “Uncharacteristic Consistency/Texture” and were closed without any written justification.
The firm closed 28 K-Y Liquibeads Vaginal Moisturizer complaints with a subject code of “Does Not Perform as Expected.”