Johnson & Johnson is recalling batches and batches of some big-selling, over-the-counter medicines after customers complained about odors of mold and mildew coming from the packages.
A musty odor has led Johnson & Johnson to recall batches of a variety of medicines, including the Tylenol pictured.
The affected products include a wide variety of Tylenol and Motrin painkillers, Rolaids antacids, St. Joseph aspirin, and Benadryl allergy tablets. Not every bottle of every drug needs to be tossed or returned. J&J's McNeil division put together a full rundown of the medicines and the particular lots the company says consumers should avoid here.
The company said in a statement that there have been a "small number of cases" of people developing temporary gastrointestinal trouble, including nausea and vomiting, after taking the medicines. The health problems were "non-serious," J&J said.
The recall widens actions taken in the last two months to deal with an odor problem for certain kinds of Tylenol and now affects a wide swath of the company's best-known brands.
What's going on? J&J says the smell is coming from a chemical called 2,4,6-tribromoanisole, or TBA. The source of the stinky stuff may be the breakdown of another chemical used to treat the wood in shipping pallets. A J&J spokeswoman told us the company has told suppliers to stop using the treated wood in pallet carrying packaging materials for the medicines.
Update: The Food and Drug Administration is pretty unhappy with J&J's handling of the problem. In a call with reporters, an agency official said the company "became aware of the problem in September 2008, and their investigation and report to the agency didn't occur until about a year later, and we would have expected action to occur sooner than that."
FDA sent a formal warning to the company on Friday, claiming it violated government quality rules. The findings during a government inspection at a factory in Puerto Rico are bracing.
The agency concludes J&J's "initial investigation into the root cause of the odor was unjustifiably delayed and terminated prematurely." Many complaints came in during four month in 2008 before the company detected a trend and got to work figuring out the cause of the problem.
The FDA said bluntly, "Neither upper management at J&J nor at McNeil Consumer Healthcare assured timely investigation and resolution of the issues." J&J has 15 working days to tell the FDA what it's going to do to resolve the problems.