* FDA probing hundreds of reports
* House lawmakers to hold J&J hearing on Thursday
* Republicans voice concern about J&J's corporate culture
* Shares down less than one percent
(Adds details from J&J memo, share price, byline)
By Susan Heavey
WASHINGTON, May 26 More than 700 complaints
about health problems in infants and children given Johnson &
Johnson (JNJ.N) medications, including 30 reports of deaths,
have been lodged with the U.S. Food and Drug Administration but
no direct link has yet been found, according to a congressional
J&J took more than 40 nonprescription products off store
shelves in late April, including Children's Tylenol, in what
the congressional staff called the largest recall of such
children's medications. The FDA received 775 complaints related
to use of the medications between January 2008 and April 2010.
Since the recall, several hundred more complaints,
including seven deaths, have been reported, the memo said.
Democratic staff on the House Oversight and Government
Reform Committee released details of the FDA investigation on
Tuesday. A U.S. House of Representatives hearing to examine
manufacturing lapses at J&J plants that led to the recall is
scheduled for Thursday.
The FDA has not disclosed how many reports its has
According to the memo, the FDA does not consider the number
of health problems reported to be above normal, and it has said
there is no "clear pattern" indicating they were caused by the
"It is the largest recall of children's medicine in the
history of the FDA," congressional staff wrote in the memo,
dated May 24, to committee lawmakers.
"At this time, FDA is not aware of any child being harmed
by taking one of the recalled products," the memo said. "FDA is
still investigating some of these adverse events to determine
if the events were related to a child taking one of the
FDA officials have repeatedly said the chance of getting
sick from the products was "remote."
J&J's Chief Executive William Weldon, recovering from back
surgery, is not expected to attend the House hearing, but
Colleen Goggins, worldwide chairman of the consumer group, is
expected to testify.
FDA Commissioner Margaret Hamburg is expected to be in
Moscow on Thursday, so her deputy, Josh Sharfstein, is due to
PROBLEMS AT J&J UNIT
The recall included infant and children's versions of pain
medicine Motrin and allergy drugs Benadryl and Zyrtec. About
"70 percent of the market for over-the-counter pediatric liquid
medicines were involved," the staff wrote in the memo.
All of the recalled drugs are made by J&J's McNeil Consumer
J&J has stopped manufacturing at its Fort Washington,
Pennsylvania, plant, as it works to rectify problems there. The
plant must be cleared by the FDA.
In late April, FDA inspectors found multiple problems,
including bacterial contamination of ingredients and filthy
equipment at the plant. They also found that some medications
made at the plant were overly concentrated and "had the
potential to be superpotent," the congressional staff wrote in
J&J is a diversified healthcare company that prides itself
on first serving patients and healthcare providers. But in a
separate document from committee Republicans, staff questioned
J&J's corporate culture and the autonomy it gives its
"Minority staff believes that there have been ongoing,
systemic failures at McNeil facilities, which have put
children's health at risk," the Republican staff wrote.
In a memo to McNeil employees, J&J said that last Friday it
gave the FDA its plan to correct the manufacturing problems and
that it was "taking steps to bring its operation back to a
level of quality that Johnson & Johnson demands of its
J&J said it has called on a third-party consultant to help
assess its plan, is improving employee training and quality
procedures, and that it has "made significant organizational
changes" to its management team at all McNeil facilities. It
will share the consultant's report with the FDA by July 15.
The head of the U.S. Senate health committee is also
investigating the recall, but so far no hearing is planned, a
spokeswoman for chairman Senator Tom Harkin has said.
Shares of J&J were down 5 cents at $60.30 in afternoon
trading on the New York Stock Exchange.
(Reporting by Susan Heavey; editing by Michele Gershberg and