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

Økonomisk planlægning

22-06-2017 09:52:24
Sponsoreret indhold:Alle har brug for en økonomisk plan. Men hvor skal du begynde? Vi forklarer hvordan i fire enkle trin.Selvom det kan virke overvældende at skulle planlægge sin økonomiske fremtid (der er så meget, der kan ske og så mange overvejelser), så behøver det ikke være stressende at lære at udarbejde en økonomisk plan, hvis du gør det rigtigt. Som alle store spørgsmål i livet er planlæg..

Aktier/tendens: Mærsk og Tryg kan komme i fokus

14-06-2017 08:08:45
A.P. Møller-Mærsk kan onsdag blive påvirket af kinesiske nøgletal og et løftet kursmål hos et større amerikansk finanshus, mens forsikringsselskabet Tryg kan blive presset af en sænket anbefaling af aktien af et italiensk finanshus.Overordnet set ventes det europæiske aktiemarked onsdag at åbne tæt på uændret, og mange investorer vil formentlig forholde sig afventende forud for resultatet af todag..

Carlsberg-konkurrent er klar til indrømmelser for britisk opkøb

13-06-2017 16:19:06
Den hollandske bryggerigigant Heineken, som blandt andet konkurrerer med Carlsberg, er parat til at komme med indrømmelser over for myndighederne i Storbritannien for at få lov til at overtage den britiske pubkæde Punch Taverns.Det skriver Bloomberg News, efter at de britiske konkurrencemyndigheder, Competition and Markets Authority (CMA), tidligere har advaret Heineken om, at selskabets overtagel..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Bavarian/Jefferies: Vaccine kan blive en milliardsællert
2
Pandora-aktien bliver shortet yderligere af amerikansk hedgefond
3
Conferize tager børsraketten med stigning på 200 pct.
4
Bavarian: Forsøg med RSV-vaccine viser stærk og bred respons - NY
5
Vestas/Jyske: Nye møller kan sikre fortsat lederskab på markedet

Relaterede aktiekurser

Johnson & Johnson 135,01 0,0% Aktiekurs uændret

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.
 
28. juni 2017 11:01:11
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20170623.1 - EUROWEB6 - 2017-06-28 11:01:11 - 2017-06-28 11:01:11 - 1 - Website: OKAY

Når du besøger Euroinvestor.dk accepterer du, at der anvendes cookies, som vi og vores samarbejdspartnere benytter til funktionalitet, statistik og markedsføring. Læs mere om cookies på Euroinvestor.dk her

x