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
Relateret debat
13 maj - 
We offer fresh cut bank instrument for lease/sale, such..

(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

Siemens vinder havmølleordre på 402 MW i Tyskland

06-07-2015 13:24:29
Siemens har vundet en ordre på levering af 67 af selskabets 6,0 MW-møller til projektet Veja Mate, der ligger i den tyske del af Nordsøen.Det oplyser det tyske ..

Aktier/åbning: Græsk smerte rammer hele C20

06-07-2015 09:17:43
Der går rystelser igennem de europæiske aktiemarkeder mandag morgen oven på den græske afvisning af de krav, som de internationale institutioner har stillet, hv..

Aktier/tendens: Store kursfald i vente fra start

06-07-2015 08:22:48
Mandag står i kursfaldenes tegn fra morgenstunden. Det sker i kølvandet af den græske afvisning af de krav, som de internationale investorer har stillet landet ..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Aktier/tendens: Store kursfald i vente fra start
2
Grækenland: Statsrenter tordner i vejret efter nej til reformer
3
Aktier/Nordea: Ser indeksfald på 4-5 pct. efter græsk nej
4
Grækenlands finansminister siger op - NY
5
Kinesiske myndigheder prøver at stoppe kursfald med nye tiltag

Relaterede aktiekurser

Johnson & Johnson 97,58 -0,9% Fald i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2015  Disclaimer Privatlivspolitik
Aktieinformation leveres af Interactive Data.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
6. juli 2015 15:51:38
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20150706.1 - EUROWEB1 - 2015-07-06 15:51:38 - 2015-07-06 15:51:38 - 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