Children's TYLENOL Recall
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.
Event: '"Johnson & Johnson's Recall Of Children's Tylenol And Other Children's Medicines"'
Committee on Oversight and Government Reform
The Full Committee
Date: Thursday, May 27, 2010 At 10:00 AM
On Thursday, May 27, 2010, The House Committee on Oversight and Government Reform will hold a hearing to examine the recall of popular pediatric medicines recalled by Johnson & Johnson subsidiary McNeil Pharmaceuticals. The hearing entitled "Johnson & Johnson's Recall of Children's Tylenol and Other Medicines" will take place at 10:00 a.m. in room 2154 Rayburn House Office Building.
The FDA received more than 700 complaints related to use of the medications from January 2008 to April 2010. In late April, J&J recalled over 40 nonprescription products, which is referred to as the largest recall of such children's medications by the congressional staff.
The recall didn't stop the complaints. Serearl hundred more came in, together with seven death reports, according to the memo.
This is the company's third recall in the past year, which triggered a flurry of criticism from congressmen. They will question company management at a hearing Thursday.
FDA is investigating whether the problems are linked to flaws in J&J products, including infant Tylenol, Benadryl and Motrin.
New detail on problems uncovered at J&J's Fort Washington, Penn. plant is expected to be provided by FDA deputy commissioner Joshua Sharfstein, who is scheduled to testify.