FDA Warns Recalled Tylenol, Motrin, Zyrtec, Benadryl, Etc Had Bacteria in It

The initial reason given for the recall was “doesn’t meet quality standards.” Specifically, the McNeil Consumer Healthcare plant in Fort Washington claimed that some products like, children and infants Tylenol, Motrin, Zyrtec, Benadryl, etc, contained higher than specified concentrations of active ingredients.  Parents were told not to worry, just buy generic products until the recall is over.

Now, a new report by the Food and Drug Administration (FDA) is telling a much different story. The FDA first met with Johnson and Johnson back in Feb 2010 to discuss a warning letter with manufacturing problems identified at the McNeil Consumer Healthcare plant .  The FDA determined that inspections should be stepped up based on the problems noted in the warning letter.

The FDA inspection report showed that ingredients in over 40 different varieties of children’s cold medicine by Johnson and Johnson were contaminated with bacteria while being manufactured at McNeil Consumer Healthcare plant. The FDA report details how inspectors found problems in April like- lack of laboratory facilities to test drug ingredients, failure to follow up with customer complaints about their product, equipment covered with “thick layers of dust,” equipment held together with duct tape, etc..  Johnson and Johnson had received over 46 complaints over the year about black/dark specks in Tylenol products, but failed to respond or investigate any of them.

FDA officials said that the finished product was not testing positive for contaminants, and serious medical problems from product use was unlikely, but such testing is not definitive. Deborah Autor, director of the FDA drug compliance office, told FOX News, “We think the risk to consumers at this point is remote.” FDA officials also said that they are considering more warning letters, and even pursuing criminal actions.  

Parent’s are being instructed to use generic alternatives. However, I think parent’s have the right to know that the recall  isn’t just about dosages being wrong or poor quality, the products were actually contaminated. Maybe it’s just me, but I find it odd that a billion dollar company would “duct tape” equipment ?