Though no direct link has been found, U.S. health regulators are investigating hundreds of reported complications with recalled children's medications made by Johnson & Johnson. According to a congressional report, the FDA sees no "clear pattern" in the "spike" of complications reported, including 30 deaths, but will will hold a hearing with officials from both the FDA and J&J over manufacturing lapses that led to contamination and to the nationwide recall of liquid children's versions of Tylenol pain reliever and other medications.
"At this time, FDA is not aware of any child being harmed by taking one of the recalled products," said the staff report, dated May 24. "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."
Recalled medicines included children's versions of pain medicine Motrin and allergy drugs such as Benadryl and Zyrtec. Despite the fact that staff said about,"70 percent of the market for over-the-counter pediatric liquid medicines were involved," the FDA said the chance of getting sick from the products was "remote."
J&J has shut down manufacturing of the liquid nonprescription medicines made at its Fort Washington, Pennsylvania, plant until it can win clearance from the FDA to resume production.
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According to Reuters, agency inspectors found multiple problems, including bacterial contamination of ingredients and filthy equipment, among other quality lapses. They also found that the products made by J&J's McNeil Consumer Healthcare unit "had the potential to be superpotent," the report said.