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OTC Product News recognized the danger early on:  that the collapse of J&J's quality systems would endanger its brand heritage and corporate integrity.  Now yet another plant is under inspection by the FDA this time a Merck/J&J joint venture facility managed by J&J that makes Pepcid, Imodium, and Mylanta, all OTC gastrointestinal products [CNN/Money].  If the same corrupted quality system controls J&J's prescription products the contagion could become a pandemic threatening it to the core.

Details within this new end-of-inspection 483 report of the Merck/J&J plant are unknown.  Yet this same plant was the subject of a "voluntary" recall of one product produced in it on November 10, 2008.  What makes this past recall germane to the current plant closures and recalls is that it occurred a full year beforehand at a "J&J" plant and it involved lots of Infants Mylicon Gas Relief Drops that may have contained metal filings.  So what we now know is that the exposure of infants and young children to defective OTC products pre-dates the current Tylenol recalls and plant closures by one year and is not new.  Until we better understand the organizational structure of J&J's quality systems we will never know the extent of the corporate contagion throughout its divisions.

Donald K. Riker, Ph.D.
Donald Kay Riker, Ph.D. is President & Founder, On Point Advisors, LLC, a consumer healthcare consultancy founded in 2007 and Editor-in-Chief, OTC Product News, the editorial voice of the consumer healthcare industry. Dr. Riker spent 20 years as a senior manager at Procter & Gamble. He was Chattem's last Vice President of R&D & Chief Scientific Officer.

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