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29-05-2012 19:44:00

J&J Unit Gets FDA Warning Letter On K-Y Vaginal Moisturizer

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By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration said a Johnson & Johnson (JNJ) unit didn't properly investigate consumer complaints related to a vaginal moisturizer.

The agency, in a warning letter dated May 22, said the company received more than 200 complaints about K-Y liquibeads vaginal moisturizer, which is made by McNeil-PPC Inc., from June 25, 2010, through Dec. 12, 2011. The agency said the complaints included reports of the product not dissolving or having an uncharacteristic consistency or texture. FDA said some of the complaints were closed without being investigated by the company. McNeil also didn't adequately investigate some complaints that contained an incorrect lot number, according to FDA.

McNeil representatives didn't immediately respond to a request for comment on the letter.

The FDA also said the company was late in submitting a report about a person being diagnosed with toxic shock syndrome after using an O.B. Tampon, also made by McNeil.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

(END) Dow Jones Newswires

May 29, 2012 13:44 ET (17:44 GMT)

Copyright (c) 2012 Dow Jones & Company, Inc.

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