Johnson & Johnson has quietly recalled some of its popular personal lubricants in order to avert potentially expensive new regulatory reviews.
In the latest in a string of J&J recalls, the health products giant’s McNeil unit removed three types of K-Y Jelly from pharmacy and grocery store shelves, and recalled packages from wholesalers, at the end of January. The recalled brands are K-Y Tingling Jelly, K-Y Sensitive Jelly and K-Y Silk-E Vaginal Moisturizer and Personal Lubricant.
McNeil said Friday that all three are safe and there are no “product performance issues,” so consumers can keep using any they have left.
But McNeil doesn’t plan to return them to the market after the company determined that each might require a detailed review by regulators. McNeil had considered them similar enough to existing products to not require such a review.
That’s because the lubricants are considered medical devices, rather than medicines. Devices that are equivalent to one already on the market can be sold without a detailed review by the U.S. Food and Drug Administration.
“As part of ongoing and detailed internal reviews we decided that these products may require submission of new data and application for a new medical device” approval, McNeil spokeswoman Samantha Lucas wrote in an email response to questions. “Because we decided against submitting new paperwork, we recalled the small amount of product that was still in the market.”
“This was a business-driven decision,” she added.
About a dozen types of K-Y Jelly are still available. One other version previously was recalled, but McNeil is working on bringing that one back.
Last July, J&J took its K-Y Liquibeads vaginal lubricant off the market, recalling about 69,000 packages of the product. The company said then that the FDA had decided Liquibeads, which the agency had approved as an extension of K-Y Intrigue lubricant, actually needed to go through the full approval process.
Lucas said Friday that the company now expects Liquibeads to be back in stores in 2014.
The lubricant recalls, reported late Thursday by the Pharmalot blog, follow about three dozen other J&J recalls of medicines and medical devices since September 2009. Those products include artificial joints, contact lenses, a couple of prescription drugs and a slew of over-the-counter medicines, including multiple adults and children’s versions of pain relievers Tylenol and Motrin.
Reasons for the recalls range from contamination with bacteria and incorrect levels of a drug’s active ingredient to liquid medicines that may contain tiny metal shavings and nauseating smells on containers.
Lost product sales and expensive, ongoing factory upgrades have cost J&J, based in New Brunswick, N.J., well over $1 billion. In addition, Johnson & Johnson’s manufacturing operations remain under increased scrutiny from the FDA.
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On The Net: http://www.k-y.com
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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma.
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