The World Ends – J&J Recalls K-Y Jelly

The World Ends – J&J Recalls K-Y Jelly

March 8th, 2013 // 7:17 pm @

A Classic FDA Auditing Trick

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.

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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 (see here).

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.

[UPDATE: 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” (you can read more here).]

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 (look here), 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.

[UPDATE: We should note that, last May, the FDA sent J&J a warning letter for various manufacturing problems that caused some K-Y products to be adulterated. These included K-Y Liquibeads; K-Y Jelly; K-Y Touch Massage 2 in 1; K-Y Sensual Silk Ultra Gel; O.B. Tampons; Reach Floss; and Stayfree and Carefree Menstrual Napkins (back story).]

The recall is only the latest in a long series of product recalls, which have included such venerable over-the-counter staples as Tylenol, Motrin, Rolaids, Sudafed and Benadryl; Acuvue contact lenses; syringes, hip replacement devices and the Topamax epilepsy drug. J&J has since sold the Rolaids brand to Sanofi as part of portfolio pruning (read here).

The OTC product recalls reflected serious manufacturing issues. A congressional investigation revealed J&J (JNJ) surreptitiously conducted recalled some products after discovering problems at its plants and hired outside contracts to work as ‘mystery shoppers’ to remove items from stores. A key plant is now being retooled and operating under a consent decree. Meanwhile, 300 jobs were cut and hundreds of millions of dollars in sales were lost.

The J&J Ethicon unit last year halted marketing of four vaginal mesh implants that have been the subject of lawsuits filed by approximately 1,000 women who claim the products have caused serious internal injuries (read here). The healthcare giant also had difficulty stocking Tampons and the Nizoral anti-fungal shampoo, the only over-the-counter shampoo that is a salve for dandruff and psoriasis.

The cumulative effect of these various recalls, which have effected all three strategic pillars – drugs, devices and consumer healthcare products – have made it harder for J&J to restore confidence among some parents, physicians and retailers. Investors, however, have downplayed the problems and decided any institutional issues are being addressed. Over the past year, J&J stock has climbed 26 percent, and this return does not include dividends.

Just the same, there will be less K-Y Jelly available to ease the ride ahead.

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