Navigation Links
FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets
Date:10/13/2009

Four Companies Required to Stop Making and Distributing Illegal Opioid Pain Relievers

SILVER SPRING, Md., Oct. 13 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs are opioid analgesics, commonly called narcotics, that are widely used to treat pain.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

These particular products have not received FDA approval and the agency has no evidence that they are safe and effective. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug. The FDA does not anticipate a supply problem for codeine sulfate tablets.

"Consumers deserve and expect that their drugs meet modern FDA standards for safety, effectiveness, labeling, and quality. Removing unapproved products that do not meet those standards is an FDA priority," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "The FDA urges drug companies to ensure all drugs they make and market have appropriate FDA approval."

The names of the products and the manufacturers and distributors that received the warning letters are:

  • Codeine Sulfate Tablets, 30 mg, 60 mg - Lehigh Valley Technologies Inc., Allentown, Penn.
  • Codeine Sulfate Tablets, 30 mg, 60 mg - Cerovene Inc., Valley Cottage, N.Y.
  • Codeine Sulfate Tablets, 30 mg - Dava International Inc., Fort Lee, N.J.
  • Codeine Sulfate Tablets, 30 mg, 60 mg - Glenmark Generics Inc. USA, Mahwah, N.J.

Companies receiving the warning letters have 15 days to give the FDA a plan to discontinue marketing the unapproved drugs. Manufacturers have 90 days to cease manufacturing of new product, and distrib
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)
2. ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
3. ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
4. Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
5. Infant Formula Manufacturers Again under Ethical Cloud: Marketing Gimmick Linked to Serious Illnesses
6. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)
7. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
8. AMT Prepares for Submission of Marketing Authorization Dossier for AMT-011 (Glybera(R))
9. Marketing of Diagnostics and deCODEme(TM), Recent Progress in Drug Development to be Highlighted at deCODE R&D Event
10. Alfacell Announces ONCONASE(R) Distribution and Marketing Agreement with Megapharm for Israel
11. FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)...   TRU-D SmartUVC LLC, producers of the ... today that the General Services Administration has awarded the ... This newly formed agreement will allow TRU-D ... purchasers, including Department of Veteran Affairs and Department of ... purchasing solutions for the Ebola effort in ...
(Date:12/22/2014)... LUXEMBOURG , Dec. 22, 2014  ConvaTec, a ... Paul Moraviec has been appointed Interim Chief Executive Officer ... Mr. Moraviec succeeds Ken Berger .  "The Board ... service in leading ConvaTec over the past three years," ... Board of Directors.  "We are confident that the company ...
(Date:12/22/2014)... Pa. and STOCKHOLM , ... (publ) (Sobi) and partner Auxilium Pharmaceuticals, Inc. today announced ... (CHMP) of the European Medicines Agency (EMA) has adopted ... clostridium histolyticum) for the treatment of adult men with ... of at least 30 degrees at the start of ...
Breaking Medicine Technology:TRU-D SmartUVC LLC Awarded General Services Administration Contract to Expand Government Customer Base 2ConvaTec Names Paul Moraviec Interim CEO Effective December 22, 2014 2Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 2Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 3Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 4Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 5Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease 6
... CARLSBAD, Calif., Aug. 4, 2011 Isis Pharmaceuticals, Inc. (Nasdaq: ... the quarter ended June 30, 2011.  The Company finished the ... loss (NOL) of $11.6 million and $24.9 million for the ... to a pro forma NOL of $15.5 million and $17.1 ...
... (Nasdaq: NKTR ) today reported its financial results for ... cash equivalents, and investments at June 30, 2011 were $481.8 million ... Revenue for the second quarter of 2011 decreased to $17.3 ... 2010.  This decrease in revenue year over year is primarily attributable ...
Cached Medicine Technology:Isis Reports Financial Results and Highlights for Second Quarter 2011 2Isis Reports Financial Results and Highlights for Second Quarter 2011 3Isis Reports Financial Results and Highlights for Second Quarter 2011 4Isis Reports Financial Results and Highlights for Second Quarter 2011 5Isis Reports Financial Results and Highlights for Second Quarter 2011 6Isis Reports Financial Results and Highlights for Second Quarter 2011 7Isis Reports Financial Results and Highlights for Second Quarter 2011 8Isis Reports Financial Results and Highlights for Second Quarter 2011 9Nektar Therapeutics Reports Second Quarter 2011 Financial Results 2Nektar Therapeutics Reports Second Quarter 2011 Financial Results 3Nektar Therapeutics Reports Second Quarter 2011 Financial Results 4Nektar Therapeutics Reports Second Quarter 2011 Financial Results 5Nektar Therapeutics Reports Second Quarter 2011 Financial Results 6Nektar Therapeutics Reports Second Quarter 2011 Financial Results 7
(Date:12/22/2014)... As part of a company-wide commitment ... San Diego and surrounding areas, Golden Care ... team with ongoing online training courses. , Online ... by Caregiverlist®. Caregiverlist® is “the premiere service ... reliable eldercare options, highest quality ratings and outstanding ...
(Date:12/22/2014)... 2014 Coral Gables is preparing to welcome ... Troopers, with its new clinic location set to open in ... hassle out of dealing with this common childhood parasite by ... two salon clinic locations in South Florida, or in the ... decision to expand developed naturally out of the demand for ...
(Date:12/22/2014)... SC (PRWEB) December 22, 2014 On ... was joined by Pastor Gordon Cashwell for an episode ... Deierlein asks Gordon, “Why is it so important to ... of Jesus?” Cashwell replies, “We all should respect who ... country was founded on Christian beliefs. That means that ...
(Date:12/22/2014)... Dec. 19, 2014 (HealthDay News) -- U.S. and state ... caramel apples that has killed at least four people ... should not eat any commercially produced, prepackaged caramel apples ... Disease Control and Prevention said in a news release. ... people had been infected with the outbreak strains of ...
(Date:12/22/2014)... NY (PRWEB) December 22, 2014 ... stronger than ever, having invested more than $5 ... service members, veterans and their families. , This ... nearly a dozen nonprofits, helping with: veteran entrepreneurship; ... scholarships; and life-coaches for severely injured veterans. , ...
Breaking Medicine News(10 mins):Health News:Golden Care Partners with Nationally Recognized Caregiver Training Service 2Health News:Professional In-Home All-Natural Lice Removal Service Expands to Coral Gables and surrounding areas. 2Health News:My Positive Perspective Celebrates Christmas With an Event to Celebrate the Birthday of Jesus 2Health News:CDC Warns of Listeria Danger From Caramel Apples 2Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 2Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 3Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 4Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 5Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 6Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 7
... OME ), the nation,s leading producer of Omega-3 fish ... of $12.1 million,($0.72 a share) for the fiscal year ... million ($0.19 a share) for the year ended December ... year ended December 31, 2007, the Company had revenues ...
... Omega 3 and Turmeric ... Supplement, ... introduce the latest addition to their family of joint,relief products, which can ... anti-inflammatory formula containing Omega 3 and,Turmeric for double strength joint relief., ...
... largely driven by new cases among gay, bisexual men, CDC ... seventh year in a row, rates of syphilis infection have ... gay and bisexual men, according to a new federal report. ... primary and secondary syphilis -- the earliest and most infectious ...
... The following,is being issued by the Foundation for ... consumer advocate will speak out against proposed legislation ... bars the sharing of private,medical information without a ... by deeming what amounts to marketing material to ...
... Pediatrics has been awarded a five-year, $2.1 million grant ... Development, part of the National Institutes of Health (NIH), ... members embark on research careers. , The grant renews ... resulted in the training of 26 UI clinician-scientists in ...
... an improvement in health-related quality of life, ... March 12 Naturopathic care is more,cost-effective than ... low-back pain, according to a study in the ... Medicine, a peer-reviewed,medical journal published by InnoVision Health ...
Cached Medicine News:Health News:Omega Protein Reports 2007 Results 2Health News:Omega Protein Reports 2007 Results 3Health News:Omega Protein Reports 2007 Results 4Health News:Omega Protein Reports 2007 Results 5Health News:The Makers of Conquer HA(TM) Launch All-Natural Double Strength Anti- Inflammatory Formula 2Health News:U.S. Syphilis Rate Grows for 7th Year in Row 2Health News:U.S. Syphilis Rate Grows for 7th Year in Row 3Health News:Consumer Advocate Speaks Out Against Bill Allowing Invasions of Medical Privacy; Author Received $21k from Bill Benefactors 2Health News:Consumer Advocate Speaks Out Against Bill Allowing Invasions of Medical Privacy; Author Received $21k from Bill Benefactors 3Health News:Consumer Advocate Speaks Out Against Bill Allowing Invasions of Medical Privacy; Author Received $21k from Bill Benefactors 4Health News:Consumer Advocate Speaks Out Against Bill Allowing Invasions of Medical Privacy; Author Received $21k from Bill Benefactors 5Health News:$2.1 million NIH grant advances U-Iowa child health research 2Health News:$2.1 million NIH grant advances U-Iowa child health research 3Health News:Study Finds Naturopathic Care for Chronic Low-Back Pain to be Efficacious, Cost-Effective 2
... these recommendations with the exceptional design and ... resulted in numerous improvements, such as:, ... holder for hassle-free storage , The system ... a flick of the lever, making transportation ...
The S4 Spinal System has quickly gained a reputation for being the next generation in pedicle screw systems because of its exceptionally small size and high biomechanical strength....
... Diagnostics is a clinical reference ... treatment and monitoring of hemostatic ... a collaboration of four laboratory ... defined vision to deliver customizable ...
All-natural porcine collagen can be used in open or laparoscopic placement....
Medicine Products: