On the heels of yet another major recall involving Johnson & Johnson, the United States government is barring the company from resuming certain operations linked to millions of bottles of defective medicine until met quality standards increase. The U.S. Food and Drug Administration and U.S. Justice Department signed a formal consent decree related to several prescription drug manufacturing sites linked to multiple drug recalls of medications. J&J units have issued 20 drug recalls or medical device recalls since September 2009 covering over-the-counter medicines such as Children's Tylenol, Benadryl, contact lenses, and DePuy hip replacements.

Johnson and Johnson, the world's biggest health products maker, is also facing more scrutiny from U.S. regulators for a unit charged with violating federal laws following multiple recalls in the past year. Legal enforcement from the government and consumer lawsuits over injuries or deaths from recalled products has intensified regulatory pressure on J&J to fix manufacturing problems that have led to the string of drug recalls and medical device recalls in the last year cost at the world's largest health-products company.

"Recent FDA inspections have confirmed that violations persist..." said the United States Justice Department. "This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity," said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research.

In addition to the Children's Tylenol and DePuy ASR hip implant recall, additional health products recently recalled by J&J include leaking Animas insulin cartridges, cracked syringes of Invega Sustenna for schizophrenia, defective Simponi injectable pens for arthritis and vials of Dermabond skin adhesive. Another J&J unit, Cordis, recently received a Food and Drug Administration warning letter citing manufacturing violations at a factory in Puerto Rico that makes heart stents. Stents are wire mesh tube-like devices that keep diseased arteries open.