New Pharma Recall Leaves More Bad Smell, Points to the Value of Effective Pallet Management

Here we go again with musty smelling pharmaceutical products, and at $900 million in lost sales and running, what arguably is turning into the most powerful serial case study ever chronicled on the downside of poor pallet management. Ortho-McNeil-Janssen Pharmaceuticals, Inc is recalling some 40,000 bottles of pills. These include 16,000 bottles of brand-name Risperdal (3 milligram tablets) and some 24,000 bottles of its generic risperidone (2 milligram tablets). The generic version is marketed by Patriot Pharmaceuticals, a wholly owned subsidiary of McNeil.

The drug Risperdal is used in the treatment of schizophrenia and other forms of psychosis.

The recall stems from two consumer reports of the products having an “uncharacteristic odor.” McNeil emphasized that TBA itself is not toxic, although the odor has made some people sick to their stomachs.

The company stated that the problem was an “uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).” It doesn’t indicate who had the “thought.”

The release then went on to say in some curious wording that “TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are transported and stored.” The implication seems to be that the treatment is used in a minority of cases but that there are a lot of pallets out there constructed of wood, so that control is justifiably difficult? “In January 2010,” the release continues, “the company instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to certify that they do not use pallets made from chemically-treated wood.”

Interestingly, McNeil does not explain that the chemical treatment “sometimes applied to wood often used” is banned in much of the world, and that the issue here is reportedly isolated to wood pallets manufactured in Puerto Rico with treated South American lumber. The company does not offer an explanation as to how such an occurrence could take place if they had actually instituted an effective risk management system.

Elaborated upon later in the release is information about their investigation:

We conducted an investigation involving our suppliers to evaluate the potential source of this TBA issue.  This investigation revealed that some of the wooden pallets used by one of our suppliers in its warehouse were contaminated with TBA.  In addition, some of the packaging components manufactured by our supplier were exposed to these pallets.  We have initiated a deeper investigation to determine the potential impact of these findings to other products.  We also are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure.

So what is the value of an effective pallet management strategy? For one, how about avoiding hundreds of millions of dollars in lost sales?

iGPS wasted no time in promoting its plastic pallet pooling solution for pharmaceutical supply chains.

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