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FDA warning letter leads J&J to recall 69,000 units of K-Y vaginal lubricant

FDA says significant changes required premarket approval
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Johnson & Johnson ($JNJ) is pulling nearly 70,000 packages of its K-Y Liquibeads Vaginal Moisturizer lubricant product off the market. It is not that there are any safety issues, the company says. It is just a matter of it not being approved by the FDA.

The company says the FDA had approved the product as an extension of its K-Y Intrigue brand lubricant, but now believes the product needs to be approved on its own. A May 22 warning letter is pretty clear about why J&J's McNeil Consumer Healthcare unit should have sought premarket approval for the consumer product or an investigational device exemption. It says J&J made "significant changes" to the product, including giving it an applicator and a gel capsule delivery system and significant labeling changes.  

The company says consumers do not need to return any of the product but it is having retailers and wholesalers send back about 69,000 packages.

The inspections at its McNeil Consumer Healthcare plant in Skillman, NJ, in December and January also spanked J&J for not thoroughly investigating 227 complaints in 18 months about the product, including nearly 70 that had some medical aspect to them.

The May warning letter to McNeil was only the latest in a very long list of issues with J&J's consumer healthcare unit. Last year, the company signed a consent decree with the FDA after it had to recall and destroy tens of millions of consumer products for a laundry list of problems that were manufactured at three other plants. And when Alex Gorsky took over the top spot in April, he promised shareholders that J&J would do better and reclaim any faith its customers had lost in its products.

- here's the AP story
- see the FDA's warning letter

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