August 24, 2010

FDA Warns Johnson & Johnson Over Two Products

The Food and Drug Administration (FDA) recently warned Johnson & Johnson that it is illegally marketing two products.

The FDA said that Johnson & Johnson's DePuy Orthopedics Inc. is selling a product that was never approved for sale, and is selling another product for uses that were not approved.

The FDA wrote in a letter to the company that DePuy is marketing its Corail Hip System for two unapproved uses, and promoting those uses in an online brochure.

The FDA also said that the company should stop selling the hip system for unapproved use and to provide information that would be needed for the agency to approve the TruMatch system.

"The FDA will evaluate the information you submit and decide whether your product may be legally marketed," stated the letter.

DePuy said in a statement that it is "reviewing the letter to understand the FDA's concerns and will respond to their request for information."

The FDA's letter was posted on the agency's website on Tuesday.  It was dated August 19 and is signed by Timothy A. Ulatowski, FDA's director of the Office of Compliance.

The letter says that the Corail Hip System is approved for total hip replacement in patients with six specific types of damage to the hip.  However, a brochure on DePuy's website says that the system can be used for treating two other conditions.

Johnson & Johnson issued its ninth product recall earlier this month that covered millions of 1 Day Acuvue TruEye contact lenses sold in Japan and two dozen other countries in Asia and Europe.  The recall followed after complaints from customers in Japan said the product gave them unusual stinging or pain when inserting the lenses.

Johnson & Johnson is already under fire by FDA officials, Congress and federal prosecutors over eight previous U.S. recalls of nonprescription medicines since last September.  Those included millions of bottles of Tylenol, other pain relievers and cold medicines for children and adults.


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