FDA Steps In At Johnson and Johnson Over Product Recalls

Contact lenses were among the products recalled by Johnson & Johnson
Contact lenses were among the products recalled by Johnson & Johnson

By now, Johnson & Johnson (J&J) executives are probably wishing that their baby shampoo slogan “No More Tears” applied to their recent encounters with the U.S. Food and Drug Administration (FDA). The FDA is stepping in at three Johnson & Johnson manufacturing plants after the company put out a slew of recalls of its products in the last 18 months. The recalls include medical devices, consumer products, and — the one that got most headlines — medications like children’s formulas of Tylenol, Benadryl and Motrin.

From typos on Sudafed packages to non-conforming cardiovascular stents, a wide range of problems have caused the New Jersey-based J&J to recall a series of products since 2009. For example, the contact lens brand, Acuvue, had to be recalled in Asia and Europe late last year after customers complained of their eyes stinging after putting in the lenses. A J&J review identified unusually high levels of an acid that had not been fully removed during the lens rinsing process at the time of manufacturing.

The 1-Day Acuvue TruEye lenses involved in the recall are composed of a flexible silicon hydrogel called narafilcon A. The company also introduced a similar Acuvue product in the U. S. under the same brand name but the material is different, narafilcon B. The difference between the two polymeric materials has been debated in online forums such as Lens 101, and J&J isn’t forthcoming as to what was it about their in-house polymer analysis that made them tweak the hydrogel for the U.S. market.

Then there were issues with a couple of medical devices. The FDA earlier this year sent a warning letter to J&J about manufacturing practices that were not up to snuff in their Puerto Rico plant where medical devices, such as cardiovascular stents, are produced. As stock market writer and analyst Melly Alazraki explains in her article on DailyFinance, “Procedures failed to ensure all devices were manufactured with consistency, and controls failed to ensure that devices conform to their specifications.”

There were also the medical devices that replaced hip sockets and put protective metal covers on hip bones fitting into the sockets. The products were recalled after too many patients had to repeat surgeries after the implants failed to work. The company also got rapped on the knuckles for illegally marketing an unapproved knee device and selling a hip implant for an unapproved use.

The list goes on. Earlier this month, five lots of leaky insulin cartridges had to be recalled by the company’s Animas unit because they weren’t releasing correct amounts of insulin, a malfunction that could be fatal for diabetic patients.

With the litany of complaints and issues, it’s not surprising that last week the company signed a consent decree with the FDA. The consent decree involves the company’s McNeil Consumer Healthcare unit from which many of J&J’s problems have stemmed with the recalls of children’s medications.The decree puts three key manufacturing plants in Puerto Rico and Pennsylvania under years of tight regulatory oversight but doesn’t involve fines or shutting down two of the three plants that are still running. As reporters Jonathan Rockoff and Jennifer Corbett Dooren explain in their Wall Street Journal article:

Under the decree, J&J must hire an outside expert to investigate the problems that prompted the FDA to formally warn the company about violations of good manufacturing practices and to develop a plan for fixing the issues. Moreover, the company will have to make sure it’s complying with the detailed terms of the 29-page document, including orders for retraining employees and for investigating all returns and consumer complaints.

With the decree, the company can’t make any products at its Fort Washington, Pa., plant until the FDA certifies its problems are fixed. The company doesn’t expect to reopen the plant this year, a J&J spokeswoman said. J&J had closed the plant last April after recalling more than 135 million bottles of Tylenol and other popular over-the-counter medicines. Since then, the company has been refitting the plant.

Source: FDA, Justice Department take action against McNeil-PPC, Inc., U.S. Food and Drug Administration News Release, 3/10/11
Source: FDA to oversee J&J plants after flood of recalls, Reuters, 3/11/11
Source: FDA set to oversee J&J plants, The Wall Street Journal, 3/11/11
Source: Johnson and Johnson recalls leaky insulin cartridges, DailyFinance, 3/08/11
Source:J&J confirms widely expanded contact lens recall, Reuters, 12/01/10
Source: Acuvue Contact Lenses Are Recalled In Asia And Europe, The New York Times, 8/23/10
Source: Johnson & Johnson Recalls Hip Implants, New York Times, 8/26/10
Image provided by nikozz and used under its Creative Commons license.

Rajendrani "Raj" Mukhopadhyay is a science writer and editor who contributes news stories and feature articles on scientific advances to a variety of magazines. Raj holds Ph.D. in biophysics from Johns Hopkins University.