J&J's Quality Control Questioned after Latest Recalls

Qmed Staff

September 13, 2013

3 Min Read
J&J's Quality Control Questioned after Latest Recalls

After a series of QC issues, Johnson & Johnson is in the limelight again with two major recalls in a one-week period. These latest recalls raise growing concerns over quality control issues at the company's manufacturing facilities.

Jansen, J&J's pharmaceutical division, recalled a lot of its injectable antipsychotic medication. The pharmaceutical, dubbed Risperdal Consta, showed signs of contamination with mold. This pill-based version of Risperdal is produced by Irish manufacturer Alkermes. For its part, Alkermes did not respond to reports, referring all questions back to J&J.

Previously, J&J recalled approximately 200,000 bottles of an infant Motrin form due to the presence of tiny plastic particles in the formula.

While recalls impact a significant number of companies regardless of size, two recalls in a one-week period could signal significant quality control issues at J&J. As one of the most trusted global companies, these back-to-back recalls could impact consumer brand perception and raise eyebrows with regulators.

In recent years, J&J has recalled products ranging from artificial hips to contact lenses. As of now, the company still operates under an ongoing FDA consent decree, promising to improve its QC processes at three different production facilities. One of J&J's production facilities in Fort Washington, PA has been closed for the past three years over QC issues."Even the most careful company is occasionally going to have a recall," stated Erik Gordon, professor at the University of Michigan and pharmaceutical industry expert. However, the latest recalls could indicate that "they're not there yet. They have not repaired the damage that was done to Johnson and Johnson's quality control infrastructure."

According to comments from J&J's PR team, the company has been making efforts to boost product quality through a streamlined supply chain process. In addition, J&J states that it is making a significant effort to detect potential problems at an early stage. The company alleges that its increased internal scrutiny has led to a higher number of recalls. "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," noted a spokesperson.

In statements shared with the press, J&J states that its latest CEO was named, in part, to improve quality control at the company. While the previous CEO, William Weldon, faced criticism for an excessive focus on cost-cutting, Alex Gorsky has stated that he will place QC issues as one of his top priorities.

Unfortunately, issues have continued at J&J. In May of this year, the company recalled a Tylenol formula for children in South Korea. In that recall, the company discovered that acetaminophen levels in the Tylenol formula were very high. Since high doses of acetaminophen are associated with liver damage, the formula could have caused significant patient injury or death. In June, the company recalled one of its birth-control pill packs in Asia, Europe and Latin America after it discovered that the pills weren't releasing hormones correctly. KY Jelly and blood glucose meters manufactured by J&J have also faced recalls in 2013.

"Maybe a company under less scrutiny would choose to wait these out as opposed to issuing a voluntary recall," notes John Gray, a 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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