Johnson & Johnson's Janssen Pharmaceutical subsidiary said Wednesday that it was recalling one lot of the antipsychotic drug Risperdal Consta.
A link to the recall notice in PDF format is here and gets a brief link on the product web site, which is deep within the Janssen web site.
Janssen's statement says the recall was issued "because the product did not meet our standards."
Reuters reported that a company spokeswoman said the more specific reason was that mold was found in some of the vials that hold the medicine. She said that the company estimates 5,000 dose packs remain in the market. A single lot has about 70,000 dosage packs. A link to the Reuters story is here.
Risperdal Consta is a long-acting, injectable version of Risperdal, which comes in a pill. Both versions are approved for use in bipolar disorder and schizophrenia. The injected version is delivered by healthcare professionals.
The recall does not apply to pill versions of Risperdal. Before losing patent protection, the pill version generated billions of dollars for the company. J&J is also under investigation by the Justice Department, which has been looking into whether the company promoted Risperdal for unapproved uses.
If patients have a reaction, they should contact their doctor.