Tylenol recall: FDA condemns poor quality control

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After Johnson & Johnson issued a recall of more than 40 different types of liquid medication this past weekend — recalling Tylenol and Motrin-branded over-the-counter cough and cold remedies for children — the U.S. Food and Drug Administration (FDA) released a report criticizing the manufacturer for a series of quality control issues at a plant in Fort Washington, Pennsylvania run by its McNeil Consumer Healthcare division. The FDA report (PDF) released Tuesday says that McNeil failed to take necessary steps to improve quality control.

As the New York Times reports, Deborah M. Autor, the director for compliance at the FDA’s Center for Drug Evaluation and Research, condemned the sloppy quality control that prompted the most recent recall — one of several recalls in recent months:

“This is yet another example of the need for companies to take full accountability for the quality of their drugs, and the serious consequences that can happen when companies do not do so.”

The FDA report, initially provided to Johnson & Johnson last Friday, indicates that McNeil purchased raw material contaminated with an as-yet unidentified bacteria. (McNeil says that these batches were rejected and not used in manufacturing, according to the Times.) While McNeil emphasizes that finished medications did not test positive for contamination, products manufactured in the affected plant were recalled as a precaution. The potential risk to consumers remains small.

Yet, apart from minimizing any actual health threat introduced by the drugs, the FDA hoped to shine a light on the faulty quality control systems that have led to several recent recalls — including a January recall of moldy-smelling Tylenol, Motrin and Rolaids products. While it remains unclear whether any further action against the manufacturer will be taken by the FDA, McNeil representatives have said in a statement that they are working with the FDA to remedy the problem:

“The quality issues that the F.D.A. has observed, many of which we had recently identified in our own quality reviews and communicated to the F.D.A., are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate.”

Visit the McNeil product recall web site to learn more about the specific products affected by the April 30th recall.