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FDA investigating recall of children's medicine

WASHINGTON (AP) - The Food and Drug Administration said Saturday it was investigating a health-care company for possible other
problems following its recall of more than 40 over-the-counter
infant's and children's liquid medications.
McNeil Consumer Healthcare, based in Fort Washington, Pa.,
issued the voluntary recall late Friday in the United States and 11
other countries after consulting with the FDA. The recall involves
children's versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and
Benadryl, because they don't meet quality standards.
The FDA said it was reviewing procedures at McNeil, which
appears to be the sole source of the problems. "We are following
through with the facility to make certain that everything has been
checked," said FDA spokeswoman Elaine Gansz Bobo.
According to McNeil and the FDA, some of the products recalled
may have a higher concentration of active ingredient than is
specified on the bottle. Others may contain particles, while still
others may contain inactive ingredients that do not meet internal
testing requirements.
The FDA called the potential for serious medical problems
"remote," but it advised consumers to stop using the medicine as
a precaution. It said a health care professional should be
consulted if a child has recently taken any of the recalled
products and is exhibiting unexpected symptoms.
The FDA also says parents in the interim should consider
substitute child medications, such as generic versions. It does not
recommend that children be given adult-strength Tylenol or Motrin
because they are not intended for younger age groups.
The medicines were made and distributed in the United States,
and exported to Canada, the Dominican Republic, Dubai, Fiji, Guam,
Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago and
Kuwait.
Details are available by telephone at 1-888-222-6036 or on the
Web at www.mcneilproductrecall.com.
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On the Net:
McNeil Product Recall Information:
http://www.mcneilproductrecall.com
Food and Drug Administration: http://www.fda.gov/medwatch

(Copyright 2010 by The Associated Press. All Rights Reserved.)


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