Risperidone and Risperdal® - Recall Due To Unusual Odor
June 21, 2011
Ortho-McNeil-Janssen Pharmaceuticals is voluntarily recalling certain lots of brand name Risperdal® and generic risperidone tablets. The two products affected are Risperdal® 3 mg tablets (NDC 50458-330-06), lot number OGG904, marketed by Ortho-McNeil-Janssen Pharmaceuticals, and risperidone 2 mg tablets (NDC 50458-593-60), lot number OIG175, marketed by Patriot Pharmaceuticals. The tablets exhibit an odor after exposure to small quantities of 2,4,6 tribromoanisole (TBA), a byproduct of a chemical preservative used to treat wooden pallets. TBA is not toxic but emits an unpleasant smell. A small number of patients have reported short term gastrointestinal side effects associated with TBA, but there are no reports of serious adverse events related to the contaminated risperidone.
Risperidone is used alone or in combination with other drugs to treat schizophrenia and bipolar mania in adults and adolescents. It is also used to treat autism-related irritability in children and adolescents.
Instruct patients not to stop taking their medication. Instruct patients to return tablets emitting the uncharacteristic odor to their pharmacy and speak to their healthcare provider. Healthcare providers or patients may call the Medical Information Recall Line at 1-800-634-8977 Monday through Friday, 9 am to 5 pm, Eastern Time, for more information. Additional information is available at www.risperdal.com and www.patriotpharmaceuticals.com
Additional information is available at the following links:
- MedWatch alert:
- Press Release:
June 21, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.