NEW YORK (AP) -- Johnson & Johnson said Monday it is taking its K-Y Liquibeads vaginal lubricant off the market because regulators believe the product needs an additional approval.
The New Brunswick, N.J., company said it there are no safety or performance issues and consumers are not being asked to return any products.
But it has instructed retailers and wholesalers to return all production lots, a total of around 69,000 packages of the product, the company said.
The Food and Drug Administration warned Johnson & Johnson by letter in late May about its failure to investigate dozens of complaints from consumers about K-Y Liquibeads in recent years.
The FDA said more than 100 complaints either weren't thoroughly evaluated, were closed without written justification or were incorrectly closed because the company believed the complaints referred to invalid production lot numbers. Its letter was based on inspections conducted in December and January.
Johnson & Johnson said the Food and Drug Administration, which approved K-Y Liquibeads as an extension of its K-Y intrigue lubricant, now believes the product needs to be approved on its own.
Shares of Johnson & Johnson rose 44 cents to close at $68 on Monday.