Navigation Links
Qualitest Pharmaceuticals Issues a Nationwide Voluntary Recall of Oral Contraceptives
Date:9/15/2011

HUNTSVILLE, Ala., Sept. 15, 2011 /PRNewswire/ -- Qualitest Pharmaceuticals today issued a voluntary, nationwide, retail-level recall of multiple lots of oral contraceptives. The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible.  This packaging error and the potential for this error to have affected other oral contraceptive products resulted in the company issuing the recall of multiple lots.

As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.  These packaging defects do not pose any immediate health risks.  However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist.   Pharmacies are being instructed to contact consumers who have received affected product.  

Qualitest is dedicated to ensuring the safe and effective use of its products, including oral contraceptives.  The source of the error is currently under investigation and the company is committed to rectifying the issue in a timely manner.

The recall is effective immediately and includes the following products:

  • Cyclafem 7/7/7
  • Cyclafem™  1/35
  • Emoquette
  • Gildess® FE 1.5/30
  • Gildess® FE 1/20
  • Orsythia
  • Previfem ®
  • Tri-Previfem®

The affected lot numbers can be found at the following URL: http://www.qualitestrx.com/pdf/OCRecall.pdf

Doctors, pharmacists or women seeking additional information on this recall, or consumers who have affected products, should contact Qualitest toll free at 1-877-300-6153 between the hours of 8:00 a.m. and 5:00 p.m. CT Monday through Friday for information or to arrange return of any affected product. The lot numbers can be found on the bottom of the box or the individual blister card.

Adverse reactions or quality problems experienced with the use of these products may be reported to Qualitest toll free at 1-877-300-6153 or to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online:www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178 

About Qualitest

Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Pharmaceuticals (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products, specialty generics and medical devices and services.  (www.endo.com).  


'/>"/>
SOURCE Endo Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Endo Pharmaceuticals Announces Agreement to Acquire Qualitest Pharmaceuticals for $1.2 Billion
2. Qualitest Pharmaceuticals Selects TrackWise® for Comprehensive Enterprise Quality and Document Management
3. Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 500 mg, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E and T023M10A and Phenobarbital Tablets, USP 32.4 mg, ND
4. Qualitest Receives FDA Approval for Emoquette™ (.15 mg Desogestrel and .03 mg Ethinyl Estradiol), an Oral Contraceptive for Prevention of Pregnancy
5. Qualitest Receives FDA Approval for Toresmide Tablets (Generic Demadex®) 5 mg, 10 mg, 20 mg, 100 mg, for the Treatment of Edema Associated with Congestive Heart Failure, Renal Disease, or Hepatic Disease
6. Qualitest Receives FDA Approval for Dexamethasone Elixir, USP, 0.5mg/ 5 mL and Orsythia™ Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.1 mg/0.02 mg)
7. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
8. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
9. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
10. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
11. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... Jan 20, 2017 Research and Markets ... Market Trends, Opportunities, and Future" report to their offering. ... This research service ... trends, and technologies, and provides a snapshot of the key participants ... and forecasts are provided from 2016 to 2020. The market is ...
(Date:1/20/2017)... January 20, 2017 Avillion LLP, a co-developer ... Mark Weinberg , MD MBA as Chief Medical Officer. Dr ... USA . ... Dr Weinberg has spent more than 17 years as a ... companies to micro-cap biotech. Over the course of his career, he ...
(Date:1/19/2017)... YORK , Jan. 19, 2017 The ... provides understanding and access to partnering deals and agreements ... - Trends in partnering deals - Top deals by ... stage of development, technology type The report provides ... entered into by the world,s leading healthcare companies. ...
Breaking Medicine Technology:
(Date:1/23/2017)... ... January 23, 2017 , ... "ProRandom is a set of camera tools that allow video ... in Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... of text with video footage. ProRandom works by using a virtual camera to create ...
(Date:1/23/2017)... (PRWEB) , ... January 23, 2017 , ... “The Inn at the Mill”: a ... unexpected fears in her quest to become happy and content. , “The Inn at ... Pennsylvania, has also lived in Germany and Vermont and is now living in Berks County ...
(Date:1/23/2017)... ... January 23, 2017 , ... “Some Infallible Characteristics of Christ”: a ... Characteristics of Christ” is the creation of published author, Rev. Dr. Robert W. Thomas, ... thirteen years, a preacher for over nineteen, a pastor for over fifteen years. He ...
(Date:1/22/2017)... Viejo, California (PRWEB) , ... January 22, 2017 , ... ... Photo Cloud to create a beautiful 3D slideshow with complete ease," said Christina Austin ... the Generators browser to place in the FCPX timeline. Presets include scenes ...
(Date:1/21/2017)... ... ... the perfect set of tools for video editors that want to create the illusion of ... CEO of Pixel Film Studios. , Video editors using ProDOF can add realistic depth ... focus from one area into the next. ProDOF comes with 0.5 second, 1.0 second, ...
Breaking Medicine News(10 mins):