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29-05-2012 22:39:00

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

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FDA NEWS RELEASE For Immediate Release: Dec. 4, 2013 Me..

(Updates with McNeil statement starting in the third paragraph.)

--FDA warns J&J unit on failure to properly investigate some consumer complaints

--Most of the letter details problems related to K-Y vaginal moisturizer

--FDA says a reporting problem related to O.B. Tampons has been adequately addressed

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.

In a statement, McNeil said it takes the issues raised by FDA seriously. "We will respond fully to their concerns and take whatever steps are needed to resolve these issues," the company said.

The warning letter was posted to the FDA's website on Tuesday. The letter stems from an inspection conducted by the FDA of a McNeil facility in Skillman, N.J. on Dec. 12, 2011 through Jan. 19, 2012.

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. However, the FDA said the company had adequately responded to the agency's concerns about that report.

Johnson & Johnson's McNeil Consumer Healthcare unit has been working to address manufacturing problems that led to recalls of Tylenol and other over-the-counter products starting in 2009. Three of the company's manufacturing plants were placed under an FDA consent decree last year and one of the plants, in Fort Washington, Pa., is still shut down.

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

(END) Dow Jones Newswires

May 29, 2012 16:39 ET (20:39 GMT)

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

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