The food and drug administration does not consider
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.
Since the April 30 recall, several hundred more cases of complications, including seven deaths, have been reported to the FDA, the report said.
When the recall was announced, FDA officials said the chance of getting sick from the products was remote.
On Thursday, the committee will hold a hearing with officials from both the FDA and JampJ over manufacturing lapses that led to contamination and a nationwide recall of liquid childrens versions of Tylenol pain reliever and other medications.
Infant and childrens versions of pain medicine Motrin and allergy drugs Benadryl and Zyrtec were also recalled. In total, about 70 percent of the market for over-the-counter pediatric liquid medicines were involved, the staff said.
It is the largest recall of childrens medicine in the history of the FDA, they wrote in the memo to committee lawmakers.
In a separate document from committee Republicans, staff questioned the corporate culture at JampJ, a diversified consumer healthcare company, and increased autonomy at its subsidiaries.
Minority staff believes that there have been ongoing, systemic failures at McNeil facilities which have put childrens health at risk, the Republican staff wrote.
JampJ 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.
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 JampJs McNeil Consumer Healthcare unit had the potential to be superpotent, the report said.
The head of the U.S. Senate health committee is also investigating the recall, but so far no hearing is planned, a spokeswoman for Committee Chairman Senator Tom Harkin has said.
Reporting by Susan Heavey editing by John Wallace source