Personal Injury Law

FDA report indicates McNeil Consumer Healthcare knew of Contamination

By LaBovick Law

A report issued  by the U.S. Food and Drug Administration (FDA) states that federal health inspectors found that Johnson & Johnson unit McNeil Consumer Healthcare (McNeil) knowingly used materials contaminated with bacteria to make certain lots of its infant's and children's Tylenol products. McNeil issued a voluntary recall on April 30 of more than 40 different sizes and flavors of seven of its most popular products, including Children's Tylenol and Children's Motrin. The company has also suspended production at its Fort Washington, Pa facility. For now, FDA officials are saying that no final product batches contain contamination, but that the agency needs to review the inspectors' assessments further to rule out any such possibilities.

Following a routine FDA inspection of McNeil's Fort Washington, Pa. facility in April, federal health officials noted the following:

'The Quality Control Unit (QA) authorities most responsible for overseeing daily operations at the Fort Washington facility did not ensure that the responsibilities of the Analytical, Microbiological, Compliance, and Quality Assurance departments were enforced for rejection and withholding from approval any raw material component that contained known contamination of gram negative organisms. Raw material…lots…had known contamination with gram negative organisms and were approved for use to manufacture several finished lots of Children's and Infant's Tylenol drug products, which remain within expiration date(s) on the market.'

The FDA's report also indicated that its inspectors found grime and thick dust covering certain types of equipment at McNeil's Fort Washington, Pa. facility. In addition, the report, dated April 30, notes that the company handled consumer complaints poorly. Reuters reports that consumers filed 46 complaints between June 2009 and April 2010 involving 'dark material in the liquid products.' The FDA is urging consumers to use generic over-the-counter medicines in place of the recalled products.

FDA: Drug maker McNeil knew of contamination – USA Today

FDA finds grime at J&J plant, urges use of generics – Reuters

FDA Inspection Report of McNeil's Fort Washington, Pa. Facility

Full post as published by LaBovick Injury Law Blog on May 06, 2010 (boomark / email).