29 maj: US GAS: Futures Slump As Traders Fear Demand Declines
29 maj: US Stocks Advance; DJIA Notches Triple-Digit Gain
29-05-2012 22:39:00

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

Relateret indhold
Relateret debat
19 mar - 
We have direct providers of Fresh Cut BG, SBLC and MTN ..
06 mar - 
Dear Sir/MA I Offer cut bank instrument for lease/sale,..
06 mar - 
Dear Sir/MA I Offer cut bank instrument for lease/sale,..

(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

Carlsberg-konkurrent frygter svækket konkurrence i Grækenland

27-03-2015 16:44:49
Konkurrencen på det græske ølmarked kan blive svækket markant set i lyset af, at de græske konkurrencemyndigheder uden betænkninger har godkendt fusionen mellem..

WDH/dir: Oticon Medical snart klar med første implantat

27-03-2015 14:23:55
William Demant Holdings kirurgiske division, Oticon Medical, fortsætter fremad for fuldt blus. Forretningsbenet har de seneste år hentet enorm vækst, og det spo..

Novo og Genmabs stiger mest blandt europæiske elitepapirer

27-03-2015 10:30:07
Novo Nordisk og Genmab topper fredag formiddag indekset over de største europæiske aktier, Stoxx 600. Med kursstigninger på henholdsvis 9,2 og 6,5 pct. distance..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Danske/Nordea: Teknik bag Mærsks salg af aktier giver medvind
2
Fredagens aktier: Pharma-udbrud kørte C20 i rekord
3
Danmark/S&P: AAA-rating med stabile udsigter bekræftes
4
FLSmidth får marokkansk ordre til 223 mio. kr. - NY
5
Dantherm: Uafklaret frasalg trækker resultat ned

Relaterede aktiekurser

Johnson & Johnson 100,34 0,2% Stigning i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Relaterede selskaber
Få adgang til information og anbefalinger af relaterede selskaber med PLUS pakken.

Du får adgang til 7 værdifulde investorværktøjer til investering.

Klik her og læs mere om PLUS pakken.

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.
 
28. marts 2015 17:00:07
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20150325.1 - EUROWEB5 - 2015-03-28 17:00:07 - 2015-03-28 17:00:07 - 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