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Voluntary recall of Risperidone
Internal Administrator
Posted: Saturday, January 7, 2012 11:27 AM
Joined: 1/14/2015
Posts: 40463

Originally posted by: JAB

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)
Tablets 3mg Bottles of 60 Tablets
NDC Code: 50458-330-06
Lot number: 0GG904
Expiration date: May 2012

Risperidone Tablets
2mg Bottles of 60 Tablets
NDC Code: 50458-593-60
Lot number: OlG175
Expiration date: OlG175
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