FDA Expands J&J Children’s Tylenol Investigation

What’s the problem?

The U.S. FDA recently announced that it would be expanding its investigation of a Johnson & Johnson manufacturing division tied to the recent recall of children’s drugs.

On May 1, 2010 J&J’s McNeil Consumer Healthcare unit recalled some 50 children’s versions of non-prescription drugs including Tylenol, Motrin, and Benadryl. Now the FDA is conducting a companywide investigation of McNeil’s “manufacturing practices to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur,” according to a statement posted Monday on the FDA website.

In announcing the recall, McNeil said that some of the children’s products may contain incorrect concentration of ingredients, ingredients that don’t meet testing requirements, and tiny metal particles. The May 6 report about the Fort Washington plant listed 20 violations. In one of them, the agency said McNeil had taken no action after receiving 46 consumer complaints on the recalled products.

A congressional committee has opened an investigation into the recall. The House Committee on Oversight and Government Reform has scheduled a hearing on May 27 to examine the recall. The panel said it had invited Johnson & Johnson Chief Executive William Weldon to testify.