WASHINGTON — The Food and Drug Administration is investigating hundreds of complaints involving children’s medicines recalled by Johnson & Johnson last month, a congressional memo says. The FDA has not directly linked any of the reports to product flaws.
J&J recalled more than 40 children’s cold medicines last month after FDA inspectors discovered a slew of manufacturing problems. The company’s third recall in the past year triggered criticism from lawmakers, who will question company managers today.
J&J declined to comment.
On Tuesday, the company posted a statement on its website saying it would restore its image by restructuring management and overhauling manufacturing.
The FDA has received reports of complications with J&J products, including seven deaths, according to the memo.
The FDA is investigating whether the problems are linked to flaws in J&J products, which include infant Tylenol, Benadryl, and Motrin. “At this time, FDA is not aware of any child being harmed by taking one of the recalled products,’’ states the memo.