RISPERDAL and Risperidone Tablets recalled due to odor of TBA

Ortho-McNeil-Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of one lot of RISPERDAL? (risperidone) 3mg Tablets, marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets, marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

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 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.

RISPERDAL? (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years.

RISPERDAL? (risperidone) is used alone or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10-17 years for the short-term treatment of bipolar mania.

RISPERDAL? (risperidone) is used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5-16 years.

Ortho-McNeil-Janssen Pharmaceuticals, Inc. has initiated these recalls in the U.S. and Puerto Rico at the wholesale and retail (pharmacy) level and is communicating this information to these customers. The company does not anticipate a product shortage resulting from this action.

Patients should not stop taking their medication. Anyone experiencing an uncharacteristic odor associated with RISPERDAL? 3mg Tablets or risperidone 2mg Tablets should return the tablets to their pharmacist, and contact their healthcare professional if they have questions. Patients or healthcare professionals can contact the Medical Information Recall Line at 1-800-634-8977 (Monday ? Friday, 9 am ? 5 pm ET).

Source: Johnson & Johnson, USA



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