During the earnings call earlier today, Chairman and Chief Executive Officer Bill Weldon provided some further context around the recent recall announcement by McNeil Consumer Healthcare. In his remarks to financial analysts Bill provided a more detailed account of what the investigation entailed and the complexities of identifying the source of the odor, which I have reprinted here for those who are interested:

“We’re very conscious of the bar we set for ourselves and that consumers expect more from us than from others because of our history and reputation. Our recent consumer product recall and FDA warning letter were important reminders of this expectation and the vigilance it requires. I want to assure you we take these matters very seriously and nothing is more important to us than the health and safety of the people who use our products.

We are undertaking a thorough review of our procedures to ensure that we identify potential improvements we could make moving forward. We believe these and other actions we are taking will address the concerns that the FDA raised in its warning letter, and we are working in close consultation with them.

When McNeil Consumer Healthcare first received some complaints on a “musty” odor associated with our products in 2008, the company conducted a microbiological investigation to check for the presence of bacteria and mold, which would be consistent with the presence of the odor. No bacteria or mold was found and it was believed that the complaints were likely an isolated issue.

When similar complaint trends were identified in 2009, the company initiated further investigation and novel forensic testing. McNeil determined that the reported uncharacteristic odor was caused by trace amounts of a chemical byproduct originating from the treatment of wood pallets used to transport and store product packaging materials.
 
Subsequently, we initiated a voluntary product recall based on broad precautionary criteria, recalling numerous product lots that had not been the subject of any consumer complaints.

Even as we continue our investigation, we have taken additional actions beyond the recall to assure product quality. We have required suppliers who ship materials to our plants to discontinue the use of the type of wood shipping pallets associated with the recall. We are conducting full inspections of all materials coming into our facilities and have had outside experts evaluate our plants. We are confident in moving forward with production and we will continue to monitor and evaluate the situation and consult with the FDA.”

Since the news of the McNeil Consumer Healthcare recall was announced last week, some questions have come up about the timing of the recall in light of when the company first became aware of the complaints about a “musty” odor.

At JNJBTW we try, whenever possible, to provide additional perspective around activities that are taking place at Johnson & Johnson. Since I’ve now learned a few things about the McNeil Consumer Healthcare recall, I thought I would pass this information on to you.

When McNeil Consumer Healthcare first received some complaints of a “musty” odor in 2008, the company conducted a microbiological investigation to check for the presence of bacteria and mold, which would be consistent with the presence of the odor. No bacteria or mold was found and it was determined that the complaints were likely an isolated issue.

When similar complaint trends were identified in 2009, the company initiated further investigation and analytical testing and determined that the reported uncharacteristic odor is caused by trace amounts of a chemical called 2,4,6-tribromoanisole (TBA) – which, as the company explained in its press release, “can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials.”

McNeil Consumer Healthcare is continuing to investigate this complex matter. They’ve used very broad criteria for the recall and, out of an abundance of caution, they have recalled product lots that they believe have the potential to be affected, even if these lots have not been the subject of any consumer complaints. In addition, McNeil has required suppliers who ship materials to their plants to stop using the type of pallets associated with the recall. The company is also conducting a full inspection of all materials coming into its manufacturing facilities and has employed outside experts on TBA to inspect facilities and review procedures moving forward. McNeil is continuing to monitor and evaluate the situation and consult with the FDA.

As they learn more, I will try to keep you informed.

In the meantime, for those who are interested in obtaining additional information about the recall announcement, including the product lots involved, you should visit McNeil’s website, where they have posted their announcement and contact information for consumers.

I just wanted to make sure that those looking for last week’s announcement from Johnson & Johnson’s McNeil Consumer Healthcare company could get to their announcement and their information about the recall. As some of you may know, last week, in consultation with the U.S. Food and Drug Administration, McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., a Johnson & Johnson company, announced a voluntary recall of certain over-the-counter products in North America, Central America and the Caribbean. For those interested in the details of this announcement, including the product lots involved, you should visit McNeil’s website, where they have posted their announcement and contact information for consumers. Rather than me explain what you should do if you have questions, I thought it best to provide what McNeil said in their release:

For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

You can also follow the latest news on the recall via the Twitter account McNeil created last week (which I tweeted about as well via @JNJComm) @McNeilRecall.

Last week’s release follows two previous recall announcements – the first on Nov. 5, 2009 when McNeil announced a recall of certain lots of Tylenol Arthritis Pain 100 Count bottles and the second on Dec. 18, 2009, when the company expanded the recall to include all lots of Tylenol Arthritis Pain 100 count with the E-Z open cap.