Another recall for J&J, as Ortho-McNeil reports odor problem with Risperdal

Ortho-McNeil-Janssen Pharmaceuticals, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), which has been plagued by a plethora of over-the-counter product recalls in the past year or so that have cost the group around $900 million in sales, says it is initiating a voluntary recall of one lot of the anti-psychotic drug Risperdal (risperidone) 3mg tablets, marketed by the company and one lot of generic risperidone 2mg tablets, sold by Patriot Pharmaceuticals, a wholly-owned subsidiary of Ortho-McNeil-Janssen.

The recalls stem from two consumer reports of an uncharacteristic odor, thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). TBA, which was also implicated in the recall of a batch of prescription HIV drug Prezista (darunavir; The Pharma Letter May 12), 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. In January 2010, 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.

While not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor. As it relates to Risperdal and risperidone, there have been no reported serious adverse events caused by the presence of TBA.