J&J Issues Voluntary Recall of Risperdal

Ortho-McNeil-Janssen, a subsidiary of Johnson & Johnson, initiated a voluntary recall of its antipsychotic medication Risperdal because of an unusual odor. The recall covers one lot of 3-mg Risperdal tablets and one lot of 2-mg risperdone tablets. Risperdone is a generic form of the drug. The Risperdal lot originally contained 16,000 bottles, but the company believes approximately 1600 remain on the market, and believes around 1200 of the original 24,000 risperdone bottles remain. The lot numbers associated with the recall can be found in the company press release.

The odor is caused by small amounts of TBA (2,4,6 tribromoanisole), a chemical associated with preservatives applied to wood and found in shipping pallets used for storing and shipping drugs. TBA is not thought to be toxic, but it produces a musty, moldy odor, and a small number of people has reported temporary gastrointestinal symptoms after exposure to the smell.