Tylenol Recall Information

Last week the FDA released the results of a new inspection report of a Johnson & Johnson manufacturing facility in Puerto Rico that had failed quality control inspections in January 2010. Yesterday, November 26, 2010 an FDA spokesperson stated:
“Clearly, this inspection shows that the company continues to have serious quality control issues at its plant and that it is not in compliance with current good manufacturing practices required by federal law”.
This statement by the FDA was about the Johnson & Johnson McNeil Consumer Healthcare unit that recalled millions of bottles of Tylenol and other over the counter drugs. However, this is the same company that recently recalled its DePuy ASR XL hip implants made by its DePuy division. It is apparent that Johnson & Johnson and DePuy had knowledge for several years that these hip implants were failing at an unacceptable rate and left them on the market.
Johnson & Johnson used to be a company with the highest standards for conduct. In fact, the Tylenol recall over two decades ago involving Tylenol on shelves that may have been tampered with is still taught in business schools around the country as the textbook example on how an ethical company should properly handle a recall.
Recently, with regard to the over the counter products, J & J was accused of a “stealth recall” in which they hired private firms to go to drug stores and purchase all the product off the shelves without disclosing a recall. This stealth recall involved children’s Motrin products as well as other popular Johnson & Johnson over-the-counter medicines.
There do not appear to be any injuries or deaths reported from the recalled over the counter products. The DePuy ASR XL hip implants, on the other hand, have subjected many hip implant patients to additional surgeries to remove the implants and exposure to cobalt and chromium poisoning that could have long lasting health effects.
It is apparent that the Johnson & Johnson Credo of quality which was like scripture within the company for so many years is not being followed by current management. Such repeated failures in the protection of public health by Johnson & Johnson would make the founders of the company roll over in their graves.
One wonders if the company suffers from a systemic failure in quality control as well as research and development. Johnson & Johnson is suffering from failures in both its medical device division as well as its pharmaceutical division. If this trend continues, consumers will start associating the brand with bad products and dangerous medical devices. No company can survive that reputation.