McNeil Facility Responsible for Recalled Drugs Cited by FDAMay 5, 2010 | Parker Waichman LLP
U.S. health regulators found serious deficiencies at the McNeil Consumer Healthcare facility that made dozens of children’s over-the-counter medicines the company recalled last week. According to a report from the Food & Drug Administration (FDA), the deficiencies at the company’s Fort Washington, PA facility could have caused bacterial contamination of raw materials in the recalled products.
On Friday, McNeil – a division of Johnson & Johnson – recalled more than 40 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid in Bottles. The recall was initiated in the U.S. and 11 other countries.
According to McNeil, some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. No adverse events have been linked to the recalled drugs.
The FDA’s report on the Fort Washington facility cites more than 20 manufacturing problems, including not properly testing for contamination of the recalled products. The agency also faulted McNeil for failing to initiate corrective action after receiving 46 consumer complaints from June 2009 to April 2010 regarding foreign materials in the drugs.
The agency has charged that McNeil knowingly used bacteria-contaminated materials to make the recalled drugs. While FDA officials said at a news conference yesterday that none of the final product have been found to be contaminated, they cautioned that a further review of inspectors’ observations is still needed to reach a firm conclusion.
The FDA continues to recommend that consumers throw away the recalled drugs and use generic versions as an alternative.
McNeil said it is making all efforts to correct the problems and has shut down production of 50 over-the-counter medications made at the facility. The FDA will follow up on the corrections and will make a decision then as to whether it should take further action against McNeil.