An odor thought to be caused by a chemical preservative has prompted a voluntary recall of certain lots of the antipsychotic drug risperidone, the Food and Drug Administration announced June 20.
Ortho-McNeil-Janssen Pharmaceuticals has recalled lots of 2 mg and 3 mg risperidone tablets, marketed as Risperdal, in response to consumer reports of an "uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole)," according to an FDA statement.
TBA, a byproduct of a chemical preservative that is sometimes applied to wood used in the construction of pallets on which materials are transported and stored, is not considered toxic but can result in an offensive odor, the statement added. A "small number" of people have described experiencing "temporary" gastrointestinal symptoms when they took products that had this odor, but no other adverse events have been reported, according to the FDA and company statements.
In January, Ortho-McNeil-Janssen required suppliers to certify that they no longer use pallets made from chemically treated wood, according to the company’s statement.
The recalled risperidone products are:
• Bottles containing 60 tablets (3 mg strength) with the lot number 0GG904, the NDC code 50458-330-06, and a May 2012 expiration date, shipped between Aug. 27, 2010, and Feb. 15, 2011.
• Bottles containing 60 tablets (2 mg strength) with the lot number OIG175, the NDC code 50458-593-60, and an Aug. 2012 expiration date, shipped between Nov. 10, 2010, and Jan. 1, 2011.
The approved uses of risperidone, an atypical antipsychotic, include the treatment of schizophrenia in adults and adolescents aged 13-17 years, short-term treatment of bipolar mania in adults and pediatric patients aged 10 and older, as well as the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.
Patients who are taking risperidone should not stop taking it, the FDA said. Those experiencing an uncharacteristic odor associated with the tablets are advised to return them to their pharmacist and contact their health care professional with any questions.