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Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of RISPERDAL® Tablets and One Lot of Risperidone Tablets
Date:6/17/2011

TITUSVILLE, N.J., June 17, 2011 /PRNewswire/ -- 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.

The RISPERDAL® lot – which includes approximately 16,000 bottles – was shipped between 8/27/2010 and 2/15/2011.  The company believes there are approximately 1,600 bottles of RISPERDAL® from this lot remaining in the marketplace.  The risperidone lot – which includes approximately 24,000 bottles – was shipped between 11/10/2010 and 1/01/2011.  The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace.  Package DescriptionNDC CodeLot NumberExpiryRISPERDAL® (risperidone)
Tablets 3mg Bottles of 60 Tablets

50458-330-06

0GG904

May 2012Risperidone Tablets
2mg Bottles o
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SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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