J&J Tightens Drug Safety

Wednesday, August 25, 2010 @ 06:08 PM gHale


Johnson & Johnson is revamping its quality controls, creating a single framework for its drug, medical device and consumer health care divisions.
The quality control reorganization comes after a number of recalls of Tylenol, Motrin and other products by McNeil Consumer Healthcare, a unit of Johnson & Johnson. The recalls have led to the temporary shut down of one manufacturing plant.
McNeil’s conduct surrounding the recalls is the subject of inquiry by the House Committee on Oversight and Investigations and by the Food and Drug Administration’s office of criminal investigations. In the last two years, F.D.A. inspectors have found significant violations of manufacturing standards at two McNeil plants, according to FDA.
In January, McNeil recalled millions of bottles of adult Tylenol, Motrin and other products made in Puerto Rico after consumers complained about a moldy or musty odor in the products. The company said a byproduct of a chemical used to treat wooden transport pallets had leached into the products, causing the moldy smell.
In April, McNeil recalled 136 million bottles of liquid children’s Tylenol and other products made at a company plant in Fort Washington, Pa. The company recalled the products because they might have contained too much of the active drug ingredient or foreign particles, the F.D.A. said.
In July, McNeil said it was starting a program to improve manufacturing and quality and it has temporarily closed the Fort Washington plant.
The recalls and plant shutdown cut Johnson & Johnson’s sales by $200 million and its earnings by 5 cents a share in the second quarter, said Dominic J. Caruso, the company’s chief financial officer. He said annual sales would decline by $600 million because of the plant closing.



Leave a Reply

You must be logged in to post a comment.