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McNeil Manufacturing Plant Cited for Deficiencies

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Serious deficiencies at a McNeil Consumer Healthcare manufacturing facility in Pennsylvania could have caused bacterial contamination of raw materials in dozens of children’s over-the-counter medicines that were recalled last week, according to a report from the U.S. Food & Drug Administration (FDA).

McNeil said it is making all efforts to correct the problems its Fort Washington, PA plant 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.

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. 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.

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. 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 continues to recommend that consumers throw away the recalled drugs and use generic versions as an alternative.

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