FDA: J&J Sold Contaminated Tylenol for 2 Years; Dragged Feet on Factory Probe

Last Updated Jan 20, 2010 11:04 AM EST

The FDA sent a blistering warning letter to Johnson & Johnson (JNJ) regarding the slow response of its McNeil Consumer unit to complaints about Tylenol bottles contaminated with a smelly fire-retardant pesticide, 2,4,6 Tribromoanisole.

The FDA says J&J knew about the problem as early as April 2008, but didn't inform the FDA until September of that year. (Companies are supposed to disclose problems to the FDA within three working days, the FDA says.)

Once that happened, J&J moved too slowly and did an investigation of the problem that was "unjustifiably delayed and terminated prematurely."

J&J's Tylenol recall has now extended to a dozen of its other over-the-counter brands. BNET noted a few days ago that in comparison to the infamous 1982 cyanide sabotage of Tylenol bottles, the company is moving painfully slowly to cure its problems. Turns out J&J is moving even more slowly than we thought: The company first learned of contamination of its Puerto Rico Tylenol plant two years ago and still hasn't fixed it.

The FDA writes that J&J started receiving complaints about smelly medicines in April 2008. Through August 2009, the company received about 112 complaints, the FDA says. The warning letter even hints that J&J was dragging its feet over the issue:

...these results were not shared with FDA until after the initiation of the inspection and following several requests for this information made by the district office.
After concluding in 2008 that the problem was not microbial, J&J simply ended its investigation instead of expanding it to other potential causes, the FDA said:
No other possible root causes were pursued. Your firm lacked adequate justification for this decision.
The letter concludes:
We have concluded that your company did not conduct a timely, comprehensive investigation.
Your initial investigation into the root cause of the odor was unjustifiably delayed and terminated prematurely.
Your firm's management, including the Quality Control Unit, was not proactive in response to consumer complaints.
Note to J&J's McNeil managers: What is wrong with you? This is Tylenol we're talking about. It's one of J&J's biggest and most valuable brands -- not something you take risks with. Have none of you read the cyanide recall history? You sold contaminated medicine for two years, didn't investigate properly, and moved so slowly to cooperate with the FDA that it looks like you were trying to cover something up. Heads need to roll.