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Johnson & Johnson Recalls Injectible Risperdal After Discovering Mold

Sep 13, 2013

Janssen Pharmaceuticals, a unit of Johnson & Johnson, has announced the recall of the schizophrenia drug Risperdal Consta.

The company is recalling the drug from wholesalers, distributors, pharmacies and healthcare providers after mold was discovered during routine testing. Consta is a long-acting form of Risperdal (risperidone) antipsychotic medication, and is used to treat bipolar disorder and schizophrenia, Reuters reports. Risperdal Consta is injected, unlike basic Risperdal, which come in pill form.

A single lot of Risperdal Consta consists of about 70,000 dosage packs and a company spokeswoman estimated that “fewer than 5,000 dose packs remain in the market,” according to an email to Reuters. Robyn Reed Frenze said that risk to patients is considered low, and "there have been no trends of adverse events of infection associated with this lot." Risperdal Consta must be administered by a healthcare professional, and patients are advised to continue prescribed treatment.

Reuters notes that in the past two years Johnson & Johnson units have recalled a variety of products, including over-the-counter drugs, contact lenses, heart devices, and insulin pump cartridges. Earlier this year Johnson & Johnson reached a settlement with the Justice Department over improper marketing of Risperdal for unapproved uses by children and adolescents, in particular that Risperdal caused breast growth (gynecomastia) in boys 10 and older who took the drug. Some young men need to undergo a mastectomy to remove the breasts.

Risperdal use in nursing homes has also come under scrutiny, as the federal government has made efforts to reduce inappropriate use of antipsychotic drugs in elderly patients. Studies have shown that these drugs increase the risk of death in elderly dementia patients, the Wall Street Journal reports.

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