In early 2008, Johnson & Johnson’s division, McNeil-PPC, that makes Tylenol received complaints about a musty odor in Tylenol bottles and some incidents of stomach pain and other digestive upsets. It did not seem to be a serious thing and nothing was done.
In September 2008, the company identified it as an issue but it was not until November 2009 that McNeil reported the issue to the FDA. At that time, McNeil recalled five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap. In December 2009 they expanded the recall to include all lots of that medication as being defective drugs.
Investigations traced the smell to some wood shipping pallets that had been sprayed with a chemical called “2,4,6-tribromoanisole” (TBA) to prevent mold.
Now on January 15, McNeil has announced a wide recall of not just the Arthritis Pain medication but also Motrin, Benadryl and others for the same reason — a moldy or mildew smell.
Warning Letter From the FDA
The FDA has given McNeil 15 days to report to the FDA on how they are addressing this problem so as to prevent any future problem. One Ira Loss, a senior health policy analyst with a company called Washington Analysis, explains that an FDA warning letter is a serious event.
“A warning letter indicates that this is the last time that the company will get a heads-up from the agency,” said Loss. “If things don’t get fixed, then there are other ways for the agency to make its point.”
The letter says in part: “… failure to correct these violations may result in legal action, including seizure and injunction.” The FDA says also that it may “withhold approval of requests for export certificates or approval of pending new drug applications” if those applications list any McNeil facility.
The pallets were traced to a Puerto Rico plant and the FDA is determining whether any other drug companies also used those pallets to ship their products.
FDA Becoming More Aggressive?
According to Loss, the FDA may be trying to make an example of McNeil as a signal to other companies. “The FDA’s been criticized for not being aggressive enough in the past,” he said. “The goal ultimately is to make the industry police itself so that we don’t end up with situations like this.”
For more information, please see our page on The Role of the FDA in Drug Recalls.
Products Included in the Recall
A McNeil spokeswoman says that about 500 lots are included in this recall expansion. Products recalled are:
- Motrin caplets
- Junior strength Motrin
- Children’s Tylenol grape meltaway tablets
- Benadryl allergy ultratab tablets
- Extra strength Rolaids fresh mint tablets
- Extra strength Tylenol
- Extra strength Tylenol rapid release gelcaps
- Extra strength Tylenol PM geltabs
- St. Joseph Aspirin chewable orange tablets
If you have been using any of these products, you can call McNeil Consumer Healthcare at 1-888-222-6036 for a replacement or a refund. Alternatively, you can go to www.mcneilproductrecall.com. Lot numbers are printed on the sides of the bottles.
If you have suffered from any illness or injury because of a defective product, please contact our law office today. We will be happy to schedule a free consultation for you with one of our experienced attorneys.