Dust, Germs and Duct Tape: How J&J Contaminated Children's Tylenol

Last Updated May 5, 2010 11:19 AM EDT

The FDA's inspection report on Johnson & Johnson (JNJ)'s Tylenol factory in Fort Washington, Pa., makes the facility look like the home of the Collyer Brothers, the legendary recluses who were found dead, trapped under their own garbage, in their Manhattan townhouse in 1947 (pictured). The FDA found bacteria, bric-a-brac, duct tape, dust, cracked equipment and -- bizarrely -- a "Restricted Storage Room" filled with random, uninventoried junk at the J&J/McNeil Consumer Healthcare unit. Like sausages and law, add over-the-counter medicines to the list of things you don't want to see being made.

The most infuriating thing for those of us who actually care about the value of J&J's brands -- Tylenol is arguably the Coca-Cola of drugs -- is how avoidable it all was. The report notes that J&J received about 46 complaints from consumers "regarding foreign materials, black or dark specks [in their drugs] from June 2009 to April 2010." J&J had known of problems since May 2009: meaning it was feeding children's and infants' Tylenol, Motrin, Zyrtec and Benadryl to consumers for a year before this current product recall.

This lapse was concurrent with a similar one at a different Tylenol factory in Puerto Rico. J&J knew since April 2008 there was something wrong with the drugs there but didn't do anything about it until January 2010.

Here's what the FDA found:

  • failed to ensure raw material didn't contain "known" contamination with gram negative organisms
  • No testing for mold or yeast
  • inadequate testing facilities
  • inadequate tracking facilities
  • inadequate manufacturing facilities, including failure of controls to ensure mix uniformity.
  • untrained staff
  • a partial drum of chemicals used instead of a full drum in a weighing mixup.
  • thick dust
  • a microbiology lab refrigeration pipe fixed with duct tape.
  • holes in the ceiling.
  • "a very large spider-like crack" on a vacuum hood in a testing room.
And the Collyer-esque coup de grace:
Restricted Storage Room located in the microbiological laboratory had excess media in boxes and special projects stored in the room with no designated areas of storage for approved, quarantine, OT rejected status. The room was cluttered with boxes of media, special projects that had bins with various containers of chemicals, special projects with boxed finished OTC products, boxes of computer items, out of service equipment, etc. Until 04/23/10, the firm had no inventory of the room contents.
Call in A&E's Hoarders crew! All it lacked was Langley Collyer's electricity-generating Model T Ford. Although no consumers have been harmed by these products, there is now no one in the U.S. who recommends they be used. The FDA suggested consumers try generics:
"Consumers should not use these products," Deborah Autor, director of the Office of Compliance at FDA's Center for Drug Evaluation and Research told reporters in a conference call, even though the chance of getting sick from the recalled products was "remote."
The media is recommending consumers move to the competition. Wal Street is wondering what the long-term effects on the company will be:
"You've got a company that's considered one of the premier companies, that's spent something like 100 years building its reputation," Les Funtleyder, an analyst with Miller Tabak & Co., said yesterday in an interview. "This is the kind of thing that can hurt that."
And the jury is still out on whether the public will give J&J a second chance (or a sixth chance, depending on how closely you've been paying attention):
The question for the company: will parents ever return to the name brand?
Related: Images from Wikimedia.