Johnson & Johnson is recalling 5,000 vials of its Risperdal Consta, a long-acting drug for patients with schizophrenia, after testing found the medicine was no longer sterile.
Routine analysis showed one lot of the injected drug was contaminated with alternaria alternata, a common mold found in the environment, said Robyn Reed Frenze, a spokeswoman for the New Brunswick-based company’s Janssen unit.
There haven’t been any reports of complications among patients who received the medicine, though injection site reactions are possible, she said.
J&J, the world’s biggest seller of health products, has been plagued by recalls for several years. The company last week withdrew about 200,000 bottles of concentrated Motrin Infants’ Drops and is facing thousands of lawsuits following the recall of 93,000 ASR model hip implants in August 2010.
“The risk to patients is low,” Frenze said. “We don’t want to create unnecessary concern,” though the company thought it was important to provide the information to doctors and others who may still have the medicine on hand, she said.
The recalled 5,000 vials are those remaining from about 70,000 originally manufactured and are mainly with wholesalers, distributors or in pharmacy or doctor’s officers, Frenze said in an interview. The medicine, approved for patients with schizophrenia and bipolar 1 disorder, generated $336 million in the second quarter. It is typically given every two weeks.
Risperdal Consta, which is refrigerated, is different from the company’s Risperdal medication, which is given orally. The recall doesn’t affect Risperdal.