The House Committee on Oversight and Government Reform has scheduled a hearing on May 27, 2010, in order to examine the recent recall of a variety of children’s over-the-counter medications by Johnson & Johnson’s pharmaceutical division, McNeil Consumer Healthcare.
As we reported on this blog earlier this month, on May 1, 2010, McNeil issued a massive recall of various children’s medications, most notably Tylenol, Motrin, and Benadryl – three of the more widely used medicines in the child population.
Following the recall, on May 4, the FDA held a media briefing [insert link] to explain the nature of the recall. Deb Autor, Director of the Office of Compliance and FDA Center for Drug Evaluation and Research, advised that
Most significant deficiencies relate to [McNeil’s] failure to sufficiently investigate and correct problems found in its manufacturing and in its drugs. Changing the manufacturing process without assuring the change would not harm the quality of the drugs and not maintaining proper facilities and procedures for testing drugs.
Then, on May 6, the FDA issued a report detailing the results of its April 19-30 inspection of McNeil’s Fort Washington, Pennsylvania manufacturing plant.
The 17-page report revealed that FDA investigators observed 20 violations relating to the manufacturing and bottling of various children’s medications, including Tylenol and Motrin infants’ preparations.
As the FDA has advised, if your child has experience any adverse reaction or unexpected symptoms while taking any of the medications listed on the recall notice, you should report the problem to a doctor immediately. If you believe your child has been seriously injured as a result of a recalled product, please contact us at our website.