Another Product Recall for Johnson and Johnson and Another Division

Johnson and Johnson, beleaguered by multiple episodes of product recalls dating back to 2009, have yet again announced a voluntary recall.  Ortho-McNeil Neurologics Division of Ortho-McNeil Pharmaceuticals, Inc., an affiliate company of J&J has issued a voluntary recall of two lots of TOPAMAX® 100 mg tablets, a drug used to treat symptoms of epilepsy.   The estimated 57,000 effected bottles were shipped to customers  about 6 months ago.  Four consumer complaints of an uncharacteristic odor thought to be trace elements of the chemical TBA were cited as the motivator of this latest recall.

Our readers will recall that complaints of odors seeping into the final product from wooden pallets were also cause for previous product recalls involving J&J’s McNeil Consumer Healthcare division. In its latest statement, J&J notes that in January, the company instituted a number of actions to reduce the potential of TBA contamination including requiring suppliers to evaluate potential sources of TBA.  The company also notes that it is working with other peer companies to better understand where TBA contamination is entering and impacting the supply chain, and where exposure can be further mitigated.

In our view, why did it take until January to initiate such an investigation, when symptoms of this specific odor problem date back to as early as 2008?

In our upcoming Q1 2011 Supply Chain Matters Quarterly Newsletter, we will provide further commentary regarding the important learning that can be garnered from what has been occurring at J&J.  A company who had a stellar reputation regarding quality, sadly, continues to respond to a supply chain and production related quality crisis with little public evidence of broad management accountability and commitment.

In the meantime, we call our readers attention to a superior analysis and insight article written by David Voreacos, Alex Nussbaum, and Greg Farrell, which was published in the April 4-April 10, 2011 edition of Bloomberg BusinessWeek. This article provides a rather comprehensive overview of the J&J crisis that actually dates back to events occurring for a decade.  What we believe is a profound takeaway from this article is that today, with all of these cascading events reflecting systemic breakdowns in quality and control processes,  The article cites industry observers pointing to decentralization, fat margins and leadership lapses as potential root causes. J&J’s CEO William Weldon continues in denial that the cascading problems lie beyond its troubled McNeil OTC division. CEO Weldon insists that the quality issues involving three plants has overshadowed activities involving over 120 plants, and fully expects that J&J will regain the trust of consumers and patients.  But as is noted in the BusinessWeek feature article, the very culture of J&J has reflected a pattern of behavior that is at odds with its public image, and spans multiple businesses and product areas.

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