Washington, DC: Risperdal and the generic risperidone have been recalled after two patients reported a bad or “uncharacteristic” odor from the antipsychotic drugs. Ortho-McNeil-Janssen Pharmaceuticals, Inc. a subsidiary of Johnson & Johnson, initiated the recall. Trace amounts of tribromoanisole (TBA) are believed to have caused the odor.
The recall includes one lot of Risperdal 3mg tablets (about 16,000 bottles), marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets (about 24,000 bottles), marketed by Patriot Pharmaceuticals, LLC, also a subsidiary of Ortho-McNeil. The Risperdal lot was shopped between 8/27/2010 and 2/15/2011; the risperidone lot was shipped between 11/10/2010 and 1/01/2011.
Although TBA is not considered toxic, it is known to produce a bad odor and some patients have reported temporary gastrointestinal symptoms when taking other medications with this same odor. TBA is sometimes used to chemically treat wood and is often used in the construction of wood pallets. Last January 2010, the pharmaceutical company required their suppliers to not use pallets made with chemically treated wood.
The FDA approved Risperdal to treat schizophrenia, but it is also used to control behavioral disorders such as delusions, aggression and anxiety associated with Alzheimer's disease and dementia.
On the heels of the Risperdal and risperidone recall, an alert was issued by the FDA (June 2011) regarding medication errors: some patients were given the generic risperidone (brand name Risperdal) instead of ropinirole (brand name Requip made by GlaxoSmithKline.), which is used to treat restless leg syndrome and Parkinson’s disease. Several patients were hospitalized and one fatality was reported. Generic risperidone was approved in 2006 and generic ropinirole was approved in 2008.
Patients have been advised to not stop taking their medication and if consumers detect an offensive odor, take your tablets back to your pharmacist and call your doctor if you have any questions.
Risperdal
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Last updated on Jun-18-11 |
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