What J&J Did Wrong With Tylenol Caplets
1 CommentBy Ed Silverman // January 16th, 2010 // 10:17 am
Not a good week to be a Johnson & Johnson executive. The health care giant and two of its units were charged by the US Justice Department with paying millions of dollars in kickbacks to Omnicare, the nation’s largest pharmacy that specializes in dispensing drugs to nursing home patients, so its Risperdal antipsychotic would be widely prescribed. You can read about that here.
That may not resonate as widely, however, as the news that J&J was also tagged by the FDA for failing to vigorously and properly follow up complaints that certain batches of its Tylenol Arthritis Relief Caplets had a musty smell. What went wrong? You can read the disturbing details not only in the FDA letter sent to J&J this week, but also the eight-page FDA enforcement report released on Jan. 8.
These activities run counter to the famed J&J Credo, which is on display in the lobby of the company’s headquarters in New Brunwick, NJ. Among the vows: ‘Everything we do must be of high quality…We must provide competent management, and their actions must be just and ethical.” Well the kickbacks charges are just that right now, charges. But if anyone - in or out of J&J - gets a headache from contemplating any of this, perhaps it would be wise to reach for something other than Tylenol.
John
Ed:
The 8-page item referenced is a US-FDA Form 483 - the form used to document deficiencies found during an inspection. Thanks for leading me to it - although I expected to see an Enforcement Report item.
The Enforcement Report is issued weekly and details recalls. The 2010 reports are located: http://www.fda.gov/safety/recalls/enforcementreports/default.htm