Approximately 16,000 bottles of schizophrenia drug - Risperdal - have been recalled by Johnson & Johnson company, Ortho-McNeil-Janssen Pharmaceuticals Inc. because of an "uncharacteristic odor".
The smell is thought to be caused by traces of a byproduct of a chemical preservative which is applied to wooden pallets - 2, 4, 6 tribromoanisole (TBA). The company says TBA is not toxic, but can give off an unpleasant smell. A very small number of patients may experience temporary gastrointestinal symptoms.
The recall affects one lot each of Risperdal (risperidone) 3 mg tablets and risperidone 2 mg tablets. While the former is marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals; the latter is marketed by Patriot Pharmaceuticals - Ortho-McNeil-Janssen Pharmaceuticals’ wholly owned subsidiary.
The recalled Risperdal lot - comprised 3mg bottles of 60 tablets; NDC Code 50458-330-06 and lot number 0GG904 - was shipped between August 27, 2010 and February 15, 2011.
Meanwhile, the recalled respiredone lot – comprising 2mg bottles of 60 tablets; NDC Code 50458-593-60 and lot number OlG175 - of approximately 24,000 bottles was shipped between November 10, 2010 and January 1, 2011.
The offensive smell, which prompted the recall of the mentioned products, was apparently a result of traces of 2, 4, 6 tribromoanisole (TBA) - a byproduct of a chemical preservative which is applied to wooden pallets. According to JNJ, even though TBA is not toxic, it can give off an unpleasant smell.
Even though it is being assured that only a very small number of patients may experience temporary gastrointestinal symptoms due to the TBA traces, JNJ has apparently worked out ways to institute a number of actions that may lower TBA contamination risk.
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