29 maj: Europæiske aktier: Nye stryg til Spanien i positivt marked
30 maj: Selskabernes forventninger - onsdag den 30 maj
29-05-2012 22:39:00

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

Relateret indhold

(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.

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
Ingen indlæg

Fondsbørsmeddelelser

Zealand Pharma kan se frem til milepælsbetaling på 4 mio. euro

22-08-2017 16:00:43
Zealand Pharma kan se frem til at modtage 4 mia. euro (30 mio. kr.) som en milepælsbetaling, efter at selskabets tyske partner, Boehringer Ingelheim, har annonceret igangsætningen af to fase-1-studier med et midler udviklet af det danske biotekselskab.De to studier skal vise mulighederne for anvendelsen af medikamenterne til behandling af fedme og/eller diabetes. Det gælder blandt andet lægemiddel..

Matas/Danske: Regnskab med lavere omsætning var forventet

22-08-2017 13:53:03
Matas' regnskab for første kvartal i det forskudte regnskabsår 2017/2018 var som forventet.Det vurderer Poul Ernst Jessen, senioranalytiker i Danske Bank.- Regnskabet er som forventet. Det eneste overraskende er ledelsesændringen, siger Poul Ernst Jessen.Materialistkædens omsætning faldt 3,2 pct. til 820,9 mio. kr., mens driftsresultatet (EBITA) var 119 mio. kr. Danske Bank forventede en omsætning..

Mærsk: Oil-salg får analytikerne til at rykke på kursmålene

22-08-2017 11:39:54
Analytikerne har primært reageret positivt på A.P. Møller-Mærsks salg af Maersk Oil.Olie- og gasdivisionen sælges til franske Total for 7,45 mia. dollar, eller 47 mia. kr., og det var mere, end de fleste analytikere havde forudset. Den ekstra værdi lægges derfor i mange tilfælde oven i aktiekursen.Eksempelvis har Nykredit lagt 400 kr. til kursmålet alene fra Oil-salget, der var 8 mia. kr. over ana..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Mærsk: Oil-salg får analytikerne til at rykke på kursmålene
2
Bavarian får godkendt aftale med Janssen af amerikanske myndigheder
3
Aktier/tendens: Jyske Bank, Matas og Unibrew tager overskrifterne
4
Tirsdagens aktier: Pandora tog revanche og stor stigning i C20 Cap
5
Zealand Pharma kan se frem til milepælsbetaling på 4 mio. euro

Relaterede aktiekurser

Johnson & Johnson 134,70 0,9% Stigning i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2017  Disclaimer Privatlivspolitik
Aktieinformation leveres af Interactive Data.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
23. august 2017 04:15:13
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20170821.2 - EUROWEB1 - 2017-08-23 04:15:13 - 2017-08-23 04:15:13 - 1 - Website: OKAY