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.

The following post is from Dr. Ed Kuffner, Sr. Director, McNeil Consumer Healthcare

Recently, there have been reports about acetaminophen, the medicine in TYLENOL® and the potential for liver damage if the medicine is misused or taken in overdose amounts. The U.S Food and Drug Administration (FDA) held a public meeting yesterday and today to discuss this very issue. As the makers of Tylenol, we share the FDA’s goal of helping to ensure that over-the-counter (OTC) and prescription medicines are used safely and properly. As a physician, I can tell you that my medical colleagues and I have been actively involved in the conversation – and are committed to finding the right solutions.

What do people need to know about acetaminophen and liver damage? Tylenol, when taken as directed, remains the safest pain reliever people can take. It’s important for people to know that it’s not the recommended dosage of acetaminophen that poses the risk. Rather, it’s when people take more than the recommended dose either intentionally, often because they think it will work better — which is not the case — or unintentionally, often because they don’t realize that several products they are taking at the same time (both prescription and OTC) each contain acetaminophen.

Importantly, you can confidently continue to take Tylenol according to the directions currently on the package and can prevent inappropriate use by:

• Reading the label before each use and always following the directions
• Never taking more than the recommended dose
• Never using two products containing acetaminophen at the same time
• Keeping medicine out of the reach of children
• Consulting a healthcare professional with questions

The safety and efficacy of acetaminophen has been established through more than 50 years of clinical use and scientific investigation and it is safe when used as directed. To learn more about the appropriate uses of Tylenol, I’d suggest you reach out to your healthcare provider, or turn to www.Tylenol.com or, if you’d like to speak to someone at McNeil directly about your questions about Tylenol, call our Consumer Call Center at 1-888-222-0082 (English and Spanish).