The Food and Drug Administration is looking into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson, according to a source close to a Congressional investigation.
Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.
The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" - and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.
Adverse event reports are consumer complaints of a serious side effect associated with the use of a medical product, according to the FDA. Adverse events could include death, hospitalization, disability and other health complications.
Following the most recent recall, Johnson & Johnson has suspended production at McNeil's facility in Fort Washington, Penn., that manufactured the children's drugs.
McNeil has maintained that its recall of the children's drugs was not "undertaken on the basis of adverse medical events" but as a precautionary measure.
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