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Johnson and Johnson Recalls Risperdal Consta Due to Mold


Johnson & Johnson is recalling one lot of the injectable schizophrenia drug Risperdal Consta after discovering mold during a routine testing process. One lot consists of about 70,000 dosage packs.

The recalled product is the 25 mg dose from lot number 309316. It was made by Alkermes Inc and shipped between January 14 and May 20, 2013.
The mold discovered, known as Alternaria alternata, is commonly found in the environment (in dust) and could cause infections around the area where the injection is given. It could also exacerbate asthma symptoms.

The risk to consumers is low, says spokesperson Robyn Reed Frenze, and there have been no reports of adverse events associated with the recalled lots. Those at higher risk for problems such as systemic infection include patients with compromised immune systems.

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Ms. Frenze estimates that fewer than 5,000 dose packs remain on the market. Because the drug is an injectable, the unused product remains in doctor’s offices, community mental health centers and pharmacies versus patients having them in their homes. The recall does not include Risperdal oral medication, which is a product a patient would have on hand at home.

Risperdal Consta is one of J&J’s top selling drugs. It is approved for use in patients with schizophrenia and bipolar 1 disorder. It is typically given every two weeks. In addition to the 25 mg vial kit, doses of Risperdal Consta also include a 12.5mg, 37.5 mg, and 50 mg injection – none of which are included in the recall.

If you have recently received a Risperdal Consta injection and experience irritation, infection or other issues related to the injection site, please contact your physician. It is important to continue treatment as prescribed. Do not change or discontinue the medication without first talking to your doctor. Keep in mind that the recall only involves one lot of the medication and your doctor will continue to have ample supply for your next visit.

If you have any questions or concerns, call the Janssen Medical Information Center at 800-Janssen (800-526-7736) Monday through Friday, 9am to 5pm EST.

Wall Street Journal
FDA – Prescribing Information for Risperdal Consta