J&J dropping lubricant products named in FDA warning letter

J&J dropping lubricant products named in FDA warning letter

March 12th, 2013 // 3:23 pm @

The website dedicated to Johnson & Johnson’s K-Y sex lubricants is populated by pictures of smiling couples. But in one corner–above the “Foreplay and Massage” link–is a very small link called “K-Y Supply and News.” What it tells those who find it is that Johnson & Johnson is under an FDA order to recall a bunch of the K-Y line products: 2 million of them.

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This is nothing new for Johnson & Johnson ($JNJ) and its McNeil Consumer Healthcare unit, which in the last few years has had to recall tens of millions of products. In fact, Pharmalot reports, this recall involves the return of 2.3 million packages.

The sticky situation stems from a warning letter McNeil received last year, spanking the OTC drugmaker for not seeking premarket approval or an investigational device exemption for alterations made to some of its K-Y line. It says J&J made “significant changes” to the products, including giving some an applicator and a gel capsule delivery system as well as significant labeling changes. The warning letter also said McNeil had not thoroughly investigated 227 complaints, 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. In 2011, the company signed a consent decree and promised to upgrade its key OTC plant. The shortages of OTC products are still dogging J&J but have not led CEO Alex Gorsky to give up the business. In January he said the company is “absolutely committed” to resolving manufacturing problems at McNeil and getting its products back on retail shelves.

The thing is, the FAQ on the K-Y Website says McNeil is giving up on the recalled K-Y products and does not intend to return those to retailers. It encourages consumers to check out “other K-Y Brand product options.”

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