FDA Takes Swipe at Tylenol Brand After Cleanliness Report
Food and Drug Administration (FDA) inspectors visited the Fort Washington, Pennsylvania facility that makes 40 products for Johnson & Johnson and what they found has them sounding an alert.
During the 11 day inspection that wrapped up last week, inspectors found thick dust and grime covered drug making equipment. There was a hole in the ceiling and duct tape was used around pipes. Raw ingredients contained unspecified bacteria, and overall there was a lack of quality control, according to the FDA report dated April 30.
The findings led the FDA on May 1, to issue a recall of 43 Tylenol brand children and infant products, including Concentrated Tylenol Infant Drops, Children’s Motrin, Children’s Zyrtec, Benadryl, and other over-the-counter products.
And in an unusual move, the FDA is now recommending that parents choose generics or private label brands over the J & J subsidiary, McNeil’s Tylenol brand children’s and infant products.
"Consumers should not use these products," Deborah Autor, director of the Office of Compliance at FDA's Center for Drug Evaluation and Research told reporters in a conference call. She adds the chance of getting sick is remote.
The FDA generally works in cooperation with drug makers to avoid costly and time-consuming litigation, but this statement marks a departure in the policy.
J & J has agreed to suspend production at the plant. The company says the findings at the plant “are unacceptable to us” reports Reuters, and that it will work closely with the FDA to fix the problems.
The FDA report says there were 46 consumer complaints about a dark material swirling around in liquid products between June 2009 and April 2010. No contamination was found in the finished drug product that was tested.
"We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there," said a statement from J&J's McNeil Consumer Healthcare unit.
Parents have already been told to stop using liquid Tylenol, Motrin, Benadryl and Zyrtec for children and infants. J & J has issued four major product recalls over the last year.
A full list of more than 40 affected products made by McNeil Consumer Healthcare can be found at www.mcneilproductrecall.com. #