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Johnson & Johnson Issues Risperdal Recall over Mold Contamination

Johnson & Johnson announced another recall last week, this time for its antipsychotic Risperdal Consta, due to concerns that the drug may not be sterile.  The Risperdal recall comes on the heels of dozens of recalls in recent years, costing the Brunswick, N.J.-based company hundreds of millions of dollars, and damaging its reputation in the medical community and among patients.

Risperdal Consta is an injectable antipsychotic drug used for the treatment of schizophrenia and bipolar disorder.  The recall was announced on September 11, after routine testing showed that at least one lot was contaminated with a common mold known as alternaria alternata.  There have been no reports of injuries linked to the contaminated vials.  The concern is that it could cause infections around the area where the injection is given.  Patients whose immune systems are compromised are at a risk of infection, the drugmaker said.

Johnson & Johnson instructed all wholesalers, distributors, pharmacies and healthcare providers to send the drug back to their facilities.  The company estimates that 5,000 of the 70,000 vials of Risperdal Consta made in a single lot last year remain unused.  Because the drug is injected, it is stored in doctor’s offices and clinics, not in patient’s homes.   It is different than Risperdal pills, which patients store in their homes.  Johnson & Johnson announced the Risperdal recall in a letter to doctors and on company websites.

The Risperdal Consta that was recalled was the 25 mg dose and from lot No. 309316.  Johnson & Johnson advised patients to continue treatment and contact their doctors with any questions.

J&J issues recalls on several medications 

Just a week before the recall, on September 7, Johnson & Johnson issued a voluntary recall for 200,000 bottles of its popular infant formula Motrin Infant Drops Original Berry Flavor.  Tiny plastic particles were discovered in the product lot before it was released to the public, according to the U.S. Food and Drug Administration.  Other recent Johnson & Johnson product recalls include Children’s Tylenol, contact lenses, and heart devices.

Risperdal recall and ongoing litigation 

The Risperdal Consta recall is the latest in a series of problems that Johnson & Johnson has had with the blockbuster drug, which had $1.4 billion in sales last year.  The drugmaker is facing a number of Risperdal lawsuits on behalf of men who suffered a condition known as gynecomastia after using the antipsychotic medicine as a child.

The Risperdal lawsuits allege that Johnson & Johnson failed to adequately warn doctors and patients about the risk of breast growth from Risperdal.  This condition has a serious effect on the quality of life of young, male patients.  In some cases, it causes the need for the surgical removal of breasts.

Johnson & Johnson’s Risperdal is also the subject of an ongoing government investigation concerning the number of children being prescribed antipsychotics.  The Office of the Inspector General (OIG) at the Department of Health and Human Services is running the investigation.  Doctors and parents have raised concerns that the drugs are being overused to treat behavioral problems, and children are being unnecessarily exposed to the side effects of Risperdal and other antipsychotics that are used for off-label purposes.