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Honey, Pass the… Uh-Oh, Johnson & Johnson (JNJ) Recalls K-Y Jelly


3/8/2013 7:41:57 AM

You read it here first. Countless couples may find it a wee bit more difficult to enjoy intimate moments, thanks to yet another recall from Johnson & Johnson. The healthcare giant, which has recalled countless products over the past three years for a variety of manufacturing and safety issues, has just pulled 2.3 million packages of K-Y Jelly. Specifically K-Y Tingling Jelly, K-Y Sensitive Jelly and K-Y SILK-E Vaginal Moisturizer and Personal Lubricant are going. Moreover, the J&J McNeil Consumer Healthcare unit has no plans to return these products to the market. The reason for the recall? A statement on the K-Y Jelly site says these three products may each require submission of new data to support a new medical device clearance, known as a 510(k). The products had been previously distributed as modifications to existing 510(k) cleared devices. As the FDA web site indicates, device makers must submit premarket notification when intending to sell a device for the first time or reintroduce a device “that will be significantly changed or modified to the extent that its safety or effectiveness could be affected (read here). A J&J spokeswoman wrote us that new data was needed because different modifications were made to the products over time, and these were either label, formulation or testing modifications. An FDA spokesperson writes us that the K-Y Sensitive Jelly "was recalled because the labeling suggests that the devices are vaginal lubricants which require 510(k) clearance to market." A new enforcement report on the agency web site indicates that the recall for Sensitive K-Y Jelly has been categorized as a Class II recall, which describes a product that may cause a temporary or reversible “adverse health consequence.” However, the J&J spokeswoman writes that there were no safety or quality issues, so consumers can continue to use however much jelly they still have.

Read at Pharmalot

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