Legal News

The FDA had some strong words for the company Johnson & Johnson over its handling over consumer complaints of strange odors from their over the counter drugs such as Tylenol, Benadryl and Motrin. CNN reports that the FDA was angry over the Johnson & Johnson recall taking so long. It had been receiving complaints of an "unusual moldy, musty or mildew-like" odor since 2008.

CNN quotes Deborah Autor, director of FDA's compliance office as saying, "When something smells bad, literally and figuratively, you aggressively investigate and solve the problem." The FDA issued a warning letter to the company that stated that it had 15 days to report back what it was doing to fix the problem and prevent future problems back in 2008 and did not receive a timely response. Getting a warning letter from the FDA is bad news. As we wrote about previous in the Common Law Blog, while these letters are not legally binding, they do allow the FDA to sue the drug company.

CNN spoke to Ira Loss, senior health policy analyst with consulting firm Washington Analysis who said that letters such as those sent by the FDA open the door to injunctions, product seizures, and other serious measures.

After being contacted again by the FDA, Johnson & Johnson revealed that the smell was caused by chemical called "2,4,6-tribromoanisole (TBA)," which is applied to wooden pallets that are used to transport and store packaging materials. Not only were the drugs smelly, but they also caused some consumers to have problems such as nausea, stomach pain, vomiting, and diarrhea.

Currently, there are the following drugs on voluntary recall: Children's Motrin, Children's Tylenol, Benadryl, Extra Strength Tylenol, Motrin IB, Regular Strength Tylenol, Rolaids, Simply Sleep, St. Joseph Aspirin, Tylenol 8 Hour, Tylenol Arthritis, and Tylenol PM.

Consumers can call 1-888-222-6036 or log on to www.mcneilproductrecall.com. The company said consumers with medical concerns should contact their health care provider

For more information, please visit our Related Resources.

Related Resources:

• McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji (FDA)
• What is an FDA Drug Marketing Enforcement Letter? (Findlaw's Common Law)
• Mcneil Consumer Healthcare Announces A Voluntary Nationwide Recall Of All Lots Of Tylenol® Arthritis Pain 100 Count With Ez-Open Cap (Findlaw)
• Pharmaceutical Liability Overview (provided by Dolan Law Firm)
• Personal Injuries from Dangerous or Defective Products (provided by Koles, Burke & Bustillo, L.L.P)