You might not realize that K-Y Jelly is a medical device but it is and the U.S. Food and Drug Administration (FDA) is not happy about claims made by Johnson & Johnson concerning the personal lubricant.

As a result McNeil Consumer Healthcare, a subsidiary of J&J, has recalled 2.3 million packages of the over-the-counter (OTC) lubricant.

On its website J&J says the K-Y Tingling Jelly, K-Y Sensitive Jelly, and K-Y Silk-E Vaginal Moisturizer and Personal Lubricant are not available on store shelves due to the recall. At the present time there are no plans to bring them back.

“There are no safety or product performance issues related to these products and you may continue to use the products you already have purchased,” the company says.

What happened?

A J&J spokeswoman says the K-Y Sensitive Jelly was recalled, “because the labeling suggests that the devices are vaginal lubricants which require 510(k) clearance to market.”  The McNeil subsidiary would need to submit new data to support the claims made by McNeil concerning each of the products.

The FDA notice sets forth a total of 1,185,664 units of product. At $14.88 per unit, J&J is taking a revenue loss of over $17 million in this recall simply for failure to comply with FDA regulations by trying to take the “fast lane” to product approval.

Previously they were distributed “as modifications to existing 510(k) cleared devices,” the company website says.

The 510(k) clearance process requires a manufacturer to notify the FDA when it plans to market a medical device. If there is a claim the product is the “substantial equivalent” of another already sold, then the company will generally be granted a clearance to sell.

However a device manufacturer needs to submit a new application to the FDA when it plans to market a device for the first time or reintroduce a device, which has had substantial changes or modifications, especially if safety and effectiveness could be affected.

The claims made by McNeil sparked the agency to consider it was going outside the scope of its original application for approval.

The FDA Enforcement Report for the week of March 6, 2013 calls this a Class II which is one that can have an “adverse health consequence” that is either temporary or reversible.

This is the latest in a long line of product recalls for J&J including Tylenol, Motrin, Benadryl, Acuvue contact lenses, the DePuy ASR hip replacement, Topamax, and the removal of four transvaginal meshes from the market as well as the closing of a company plant in Fort Washington and Lancaster, Pennsylvania due to contamination.

While the company may be taking a hit in the public relations department, investors seem to be well lubricated in their view of the company. A heavily diversified company with more than 200 divisions, J&J the stock has risen 26 percent over the past year.