J&J Issues Second Drug Recall in 1 Week
Johnson & Johnson’s pharmaceutical unit, Janssen, has issued a drug recall for one lot of the schizophrenia drug, Risperdal Consta. The injectable antipsychotic was found to have mold in it after testing.
According to the pharmaceutical company, both this and the previous recall, for Infant’s Motrin, involved ingredients manufactured outside of the company.
Risperdal Consta is a long-acting version of Risperdal, which is available in pill form. The drug can only be administered in a doctor’s office or clinic.
Johnson & Johnson issued a statement that the mold posed little threat to patients on the drug, and they have received no reports of serious harm. The mold is commonly found in the environment and only patients with very compromised immune systems would be effected.
“We estimate that fewer than 5,000 dose packs remain in the market considering our current inventory levels and the usage of this product,” spokeswoman Robyn Reed Frenze said in an email to Reuters. A single lot of Risperdal Consta consists about 70,000 dosage packs. J&J issued the drug recall primarily out of caution.
Although neither drug recall involved serious personal injury, they come at a troubling time for the company which says it has been working to improve quality after recently settling a series of personal injury and wrongful death lawsuits involving Tylenol. J&J suffered major drug recalls for two years, between 2008 and 2010, when it had to withdraw more than 40 brands of children’s Tylenol, Motrin, and other medications that reportedly had foul odors. An FDA investigation team found that ingredients and equipment in J&J’s Fort Washington, Pennsylvania facility had bacterial contamination that led to the smell. After contamination was discovered, J&J agreed to close down one factory for overhaul, and signed a consent decree that expanded US oversight of three other plants.
“Even the most careful company is occasionally going to have a recall,” said Erik Gordon, who teaches business at the University of Michigan and follows the pharmaceutical industry. He added, however, that the frequent drug recalls indicate that “they’re not there yet. They have not repaired the damage that was done to Johnson and Johnson’s quality control infrastructure.”
Ernie Knewitz, a spokesman for Johnson & Johnson, said, “Our goal is to minimize recalls, and yet when we recall a product, we are acting in the best interest of the consumers of our products.”
Other critics, however, believe that the drug recalls are an abundance of caution, which is part of the overhaul of the company’s image and quality, on Johnson & Johnson’s part.
“Maybe a company under less scrutiny would choose to wait these out as opposed to issuing a voluntary recall,” said John Gray, an associate professor at the Fisher College of Business at Ohio State University. “Given everything that’s happened, I would expect that Johnson & Johnson has a pretty heavy focus on quality right now.”
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