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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

in the United States dedicated solely to mental health. Janssen currently markets prescription medications for the treatment of schizophrenia, Bipolar 1 Disorder, and schizoaffective disorder. Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a member of the Johnson & Johnson Family of Companies. For more information about Janssen, visit http://www.janssen.com.

About Patriot Pharmaceuticals, LLCPatriot Pharmaceuticals, LLC is a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc.  The company markets and distributes authorized generic pharmaceuticals, including itraconazole, ketoconazole, galantamine, Tramadol HCl ER 100mg and 200mg and risperidone. Patriot is located in Horsham, PA.

Important Safety Information About RISPERDAL® and Risperidone Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

The most common adverse reactions observed in all clinical trials with RISPERDAL® occurring at a rate of at least 10% were drowsiness, increased appetite, fatigue, insomnia, sedation, tremor, muscle stiffness , vomiting, coughing, constipation, stuffy nose,  runny nose, drooling, dry mouth, abdominal pain, dizziness, nausea, anxiety, headache, nasal congestion , common cold, rash, and restlessness.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has
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SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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