Monday, May 3, 2010

Recall: Kids' Motrin, Tylenol, Benadryl, Zyrtec

A division of Johnson & Johnson recalled over-the-counter (OTC) infants' s and children's liquid formulations of Motrin, Tylenol, Tylenol Plus, Benadryl and Zyrtec. This major recall by McNeil Consumer Products, announced Friday night, involves all non-expired lots for more than 40 products, representing over 1,000 lots. While McNeil provides a list of all products involved - also available on the US Food and Drug Administration (FDA) site, it appears that this list represents all forms for the infants' and children's liquid medicines listed above.

The FDA and McNeil recommend that, as a precautionary measure, parents not administer any of the medications on the list. FDA Commissioner Margaret A. Hamburg called the potential for serious health problems resulting from these products "remote."

No injuries or deaths occurred, and the FDA says that the recall is not being undertaken on the basis of adverse medical events. According to the Washington Post, this recall is consecutive to an April 19, 2010 FDA inspection of the production site, which uncovered what the FDA calls "manufacturing deficiencies." McNeil's news release indicates that "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."

Parents can replace these infants' and children's medicines by their generic equivalents. The generic equivalent is acetaminophen for Tylenol, ibuprofen for Motrin, diphenhydramine for Benadryl, and cetirizine fror Zyrtec. The FDA states that parents should not substitute adults medications for children's formulations.

McNeil's recall site gives instructions on safe disposal of these medications, and on how to get refunds. The New York Times Bucks blog also discusses the refund process.

The FDA press release provides an excellent summary of the critical facts. More information is available on WebMD,  the Washington Post, AP, The New York Times, the Wall Street JournalMedPage Today, and the Chicago Tribune.

McNeil Consumer HealthCare Press Release

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