Risperdal Consta Recall Issued Due to Mold Contamination

Johnson & Johnson has issued a recall for Risperdal Consta, impacting about 5,000 vials of the long-acting version of the schizophrenia, due to potential concerns that the injectable drug may not be sterile.  

The Risperdal recall (PDF) was announced this week by Johnson & Johnson subsidiary Janssen Pharmaceuticals, after routine testing determined that at least one lot of the injectable antipsychotic was contaminated with a common mold known as alternaria alternata. There have been no reports of illness linked to the contaminated vials.

The 25 mg injections are given by doctors and Johnson & Johnson did not publicly release the lot number or NDC of the vials affected. The company said that the risk to patients was low and that the supply of Risperdal Consta will not be affected by the recall.

There were originally 70,000 of the vials in the affected lot, but Johnson & Johnson officials believe that only about 5,000 of those remain in circulation and are in the hands of wholesalers, pharmacies and doctors’ offices. The recall has no effect on other size doses of Risperdal Consta or on the pill form of Risperdal, company officials say.

Risperdal is a blockbuster drug for the company, with $1.4 billion in sales last year.

The recall comes just days after Johnson & Johnson recalled about 200,000 bottles of concentrated Motrin infant drops because they could be contaminated with plastic debris.

The company is struggling to rebuild its drug safety image after being stricken by years of recalls due to quality control problems, including a massive children’s drug recall issued in April 2010 due to manufacturing problems.

National attention was focused on Johnson & Johnson’s OTC drugs after an April 2010 recall of Tylenol, Benadryl and Motrin, which affected affected 136 million bottles of children’s medications. That recall resulted in the shutdown of the company’s Ft. Washington, Pennsylvania, plant and the temporary suspension of the production of all children medications manufactured by their McNeil subsidiary. Inspectors found a number of problems at the facility that included poor quality control measures, and inadequate and sometimes disjointed tracking and responses to consumer complaints.

Growing Risperdal Lawsuits Over Side Effects

This latest recall also comes as Johnson & Johnson continues to face a number of Risperdal lawsuits filed on behalf of former male users who experienced problems with breast growth after using the antipsychotic medication as a child.

The cases allege that the drug maker failed to adequately warn young, male users or the medical community about the risk of breast growth from Risperdal side effects, which involves a condition known as gynecomastia. This is a serious medical condition that has a substantial impact on the child’s quality of life and often results in the need for surgical removal of breasts.

Johnson & Johnson also faces an ongoing government investigation involving Risperdal, which is examining the large number of children being prescribed antipsychotics. The investigation was launched by the Office of the Inspector General (OIG) at the Department of Health and Human Services (DHHS).

Both older antipsychotics and newer atypical antipsychotics are included in the investigation. Some of those drugs have actually been approved for treatment of children with behavior disorders, such as bipolar and schizophrenia, while others are often prescribed “off-label” by doctors, for indications that have not been approved by the FDA as safe and effective.

Doctors and parents have raised concerns that the drugs are being overused to treat behavioral problems, unnecessarily exposing children to the risk of side effects from antipsychotics.