Oops... J&J Recalls Another 9 Million Tylenol Bottles

Now we know why supercomputers were invented. They are needed to keep track of the escalating, to-the-heavens number of bottles of over-the-counter medicines that Johnson & Johnson is recalling. The latest batch involves a mere nine million Tylenol bottles after an internal review found required info about a small amount of alcohol in the flavoring was not listed on the front of the packaging. A J&J spokeswoman says the move was posted yesterday on theTylenol web site.

However, the bottles are only being recalled from pharmacies and distributors, given that there was no evidence of adverse events. The same rationale was used earlier this month when Johnson & Johnson's troubled McNeil Consumer Healthcare unit yanked about four million packages of children’s Benadryl allergy tablets and about 800,000 bottles of children’s Motrin caplets.

This is only the latest in a seemingly, never-ending series of such recalls by the health care giant, which has so far yanked some 200 million of bottles of different over-the-counter medicine brands, including many pediatric products, after uncovering musty smells, metallic flecks or too much active ingredient.

For those wondering just how bad the manufacturing problems have been, you can read a heavily redacted FDA enforcement report, known in the industry as a 483 form, that recounts a laundry list of violations found during various plant inspections of the Las Piedras facility in Puerto Rico. All sorts of issues were not only discovered but, in some cases, remained uncorrected as recently as Nov. 2, which was the date of the most recent visit by FDA inspectors (look here).

Meanwhile, the string of recalls (here's a partial list) has led to a plant closing in Fort Washington, Pa., where 300 jobs were lost; embarassing Congressional hearings; federal and state investigations; waning consumer confidence; a corporate shake-up of uncertain dimensions, and at least $600 million in lost sales this year (background here, here, here, here and here).