The only thing more certain than stinky Tylenol this year is that there would be a lawsuit from consumers at some point, and now it’s happened. Five times, in fact. They’ve been filed against Johnson & Johnson’s McNeil Consumer Healthcare unit and seek class action status, and accuse J&J/McNeil of failing to properly recall the bad drugs and of failing to adequately compensate consumers.
Should Tylenol have been recalled sooner? FDA inspection reports going back to 2003 paint a queasy picture.
Oopsy-poopsies! Johnson and Johnson forgot to recall four “lots” of Benadryl Allergy Ultratabs and one lot of Extra Strength Tylenol Rapid Release Gels along with the dozens already recalled in Jan. J&J took the pills off the market after consumers complained they smelled moldy and in a few cases, caused vomiting and diarrhea.
Ever since the FDA and Congress started asking Johnson & Johnson to explain why it keeps recalling medicine, there have been references to an unpublicized “recall” that happened in November 2008. Last month, at a hearing of the House Oversight and Government Reform Committee, a J&J executive swore that the company didn’t mean to mislead anyone. It turns out that wasn’t exactly accurate: Bloomberg has obtained emails from J&J’s company, McNeil Consumer Healthcare, that show executives knew the secret recall would trigger an FDA reaction if the agency got wind of its full scope.
Blacksmith Brands bought the PediaCare line of children’s cough and cold medicines from Johnson & Johnson last November. Unfortunately, the company hadn’t switched production over to a different facility, so last Friday it had to recall nearly 100,000 bottles that are guilty by association. There have been no complaints so far about the products, but when your manufacturer is under investigation by the FDA’s criminal division you tend to want to play it safe.
The manufacturing plant that has been the cause of Johnson & Johnson’s latest in a string of recalls has already been described as dirty and poorly maintained. It turns out that it was also staffed with temps and contract employees who weren’t properly trained, according to tax records and an FDA inspection report filed earlier this year.
One of the implied promises of a brand name, especially when it comes to drugs, is you can expect higher quality, but maybe that doesn’t apply when it comes to McNeil products.The FDA says the plant that produced the recently recalled children’s Tylenol, Motrin, Zyrtec and Benadryl, was using raw materials that were contaminated with bacteria. The plant also lacked adequate quality-control procedures and was dirty. So far none of the recalled medicine has tested positive for bacterial contamination, but the FDA report suggests that the contaminated material was used to make the recalled lots. The plant has been shut down indefinitely.