Johnson & Johnson’s Sluggish Action on Tainted Products Draws Harsh Criticism

McNeil-PPC, a division of consumer product giant Johnson & Johnson, first began receiving complaints regarding a moldy associated with Tylenol Arthritis Relief caplets in early 2008. Consumer incidents of temporary digestive problems such as nausea, vomiting and stomach pain after ingesting the medication were also reported. However, it was not until late in 2009 that the company issued a voluntary recall of certain lots of the product, followed by a substantial expansion of the recall just prior to the end of the year. 

On the heels of that recall, late last week McNeil launched a much more massive recall of approximately 500 drug lots due to consumer complaints of the drugs having a moldy odor. In all, 27 products in various packaging quantities are affected, amounting to more than 53 million bottles of popular over-the-counter medications such as Tylenol, Motrin, Rolaids, Benadryl and St. Joseph’s Aspirin. The recall announcement drew harsh criticism from the U.S. Food and Drug Administration (FDA) for the company’s failure to take timely action in addressing a problem of such huge proportions. The problem with the tainted pills is believed to stem from issues in a Puerto Rico facility.

Johnson & Johnson’s slow response to continued reports of adverse consumer incidents is a far cry from that demonstrated in 1982, following several deaths associated with the consumption of tainted Tylenol tablets. At that time, the swift reaction to the crisis at hand was regarded as nothing less than exemplary. According to Deborah Autor, director of the FDA's Office of Compliance, “McNeil should have acted faster." She then added, “When something smells bad, literally or figuratively, they must aggressively investigate and solve the problem.”

In a letter to McNeil dated January 8, 2010, the FDA referred to complaints about at least two of the company’s products having an “uncharacteristic smell,” similar to that noticed with the arthritis caplets. The authors cited more than 39 complaints regarding Tylenol Extra Strength, including three reports of adverse events, as well as over 10 “musty-moldy odor” complaints regarding Rolaids. In addition, they wrote, “Since the date of the discovery, your firm did not extend the assessment of the event to other products that received packaging components from the same supplier.”