Ortho-McNeil-Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, recalled about 16,000 bottles of its Risperdal schizophrenia drug on reports of an uncharacteristic odor. The recall affects one lot that was shipped between Aug. 27, 2010, and Feb. 15, 2011.
Specific recalls include;
- Risperdal Tablets 3 mg – Bottles of 60 tablets – NDC Code 50458-330-06 – Lot Number 0GG904 – Expiry May 2012
- Risperidone Tablets 3 mg – Bottles of 60 tablets – NDC Code 50458-593-60 – Lot Number OlG175 – Expiry August 2012
It is thought to contain trace amounts of 2, 4, 6 tribromoanisole, or TBA, the byproduct of a chemical preservative sometimes applied to wooden pallets. Although it isn't considered toxic, TBA can generate an offensive odor, the company said. A very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor.
Risperdal is used for the treatment of schizophrenia in adults and adolescents ages 13 – 17 years. Risperidone is used alone or in combination with other medicines in adults for the short-term treatment of bipolar mania or alone in adults, children and adolescents ages 10 – 17 years for the short-term treatment of bipolar mania. It is also used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5 – 16 years.