U.S. health officials are investigating hundreds of complications that have been reported with several recalled Johnson & Johnson liquid children’s medicines, but have not uncovered a direct link, according to Congressional documents.
The Food and Drug Administration did not find an apparent connection between the 775 incidents, which included 30 deaths, and dozens of recalled products, the Democratic staff of the House Oversight and Government Reform Committee said in a report released Tuesday.
“At this time, FDA is not aware of any child being harmed by taking one of the recalled products,” said the May 24 document. “FDA is still investigating some of these adverse events to determine if the events were related to a child taking one of the recalled medicines.”
J&J’s McNeil Consumer Healthcare recalled more than 40 over-the-counter brands of children and infant liquid cold and allergy medications — including Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl — after the FDA said that they did not meet quality standards.
At the time of the April recall, the FDA said on its website that “the potential for serious medical events [was] remote,” but advised consumers to discontinue use of the products. Since then, several hundred more health issues have been reported, including seven deaths.
In total, about “70 percent of the market for over-the-counter pediatric liquid medicines were involved,” the Democratic staff said.
“It is the largest recall of children’s medicine in the history of the FDA.”
Republican committee staff said in a separate document that minority employees at J&J believe there are “ongoing systemic failures” at the McNeil facilities that put children’s health at risk.
J&J has shut down manufacturing of liquid nonprescription medicines at its Fort Washington, Pennsylvania, plant until the FDA allows it to reopen.
The issues the FDA inspectors found at the facility included bacterial contamination of ingredients and dirty equipment and concluded that the products made “had the potential to be superpotent.”
On Thursday, the committee is holding a meeting with the FDA and J&J to discuss the contamination and recall of the children and infant medications.
The head of the U.S. Senate health committee is also investigating the recall.