Navigation Links
Federal Government Obtains Permanent Injunction Against Deltex Pharmaceuticals Inc.

SILVER SPRING, Md., Jan. 18, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan.


The consent decree permanently prohibits/stops the company, Ahmed, and Khan from manufacturing and distributing drug products until Deltex's manufacturing operations and products are in compliance with federal law and the terms of the consent decree.

Deltex is a contract manufacturer and distributor of prescription and over-the-counter (OTC) drug products. The government's complaint, filed by the U.S. Department of Justice, detailed violations of the Federal Food, Drug, and Cosmetic Act involving manufacturing and distributing unapproved, adulterated, and misbranded drugs. Specifically, Deltex failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manufacturing practice (cGMP) requirements.

"This injunction shows that FDA will seek enforcement action against companies that are identified as being in violation of our manufacturing and drug approval requirements," said Dara A Corrigan, FDA's associate commissioner for regulatory affairs.

The FDA provided ample prior notice to Deltex, a company with a history of significant violations of cGMP requirements, to cease marketing unapproved, adulterated, and misbranded drugs. FDA inspections of Deltex repeatedly found evidence that the defendants manufacture and distribute unapproved, adulterated, and misbranded drugs.

The FDA issued a Warning Letter to Deltex for manufacturing unapproved drugs and for deviations from cGMP requirements. Since the issuance of the Warning Letter, the company continued to manufacture and distribute unapproved new drugs and continued to fail to comply with cGMP regulations.

Under the terms of the consent decree, the defendants cannot resume manufacturing and distributing any drug until Deltex complies with cGMP requirements.  Additionally, the defendants cannot resume distributing any drug until such drug is approved by FDA or it complies with OTC drug monographs, the regulatory mechanism for legally marketing many non-prescription or OTC drugs.

Further, the defendants must recall drugs that were manufactured and distributed since Oct. 31, 2008 from their customers and destroy the recalled drugs, and additionally advise their customers to recall products at the retail level. The consent decree also subjects the defendants to penalties of $2,500 per day if they fail to comply with any of the provisions of the consent decree, and an additional $500 for each violation.

For more information:

Media Inquiries: Christopher Kelly, 301-796-4676,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Federal Funding Awarded to Test Antimicrobial Properties of Copper Metals
2. Enrollment of Women in Cardiovascular Trials Fails to Meet Current Federal Mandates
3. State, Federal Officials Remind Health Care Workers, Other at-Risk Individuals to Get Annual Flu Shot
4. New Federal Stem Cell Rules Would Hinder Existing Research, Consumer Group Warns
5. Mars, Incorporated Commits Over $2 Million to Federal Agency for Human-Animal Interaction Research
6. Southern Research to Play Key Role in the Federal Governments Search for New Cancer Therapies
7. Childrens Hospital Receives Six-Year Federal Contract to Study Antibiotic Use in Children With Urinary Tract Infections
8. Faced With Federal Prosecution, MountainView Agrees to Stop Harassment of RNs in Settlement With Labor Board
9. Malaria Experts Call on Federal Government to Increase Support for Research and Development
10. Federal Judge Rejects GlaxoSmithKlines Claims of Privilege
11. Chesley Files Federal Zicam Lawsuits
Post Your Comments:
(Date:9/28/2017)... CHICAGO , Sept. 28, 2017 Hill-Rom ... quarter 2017 earnings conference call and webcast on Friday, ... 8:00 a.m. (EDT) and ending at approximately 8:30 a.m. ... to discussing the company,s 2017 financial performance and guidance ... growth opportunities, initiatives to enhance operational performance, and long-range ...
(Date:9/27/2017)... -- Commended for their devotion to personalized service, SMP Pharmacy Solutions ... in the South Florida Business Journal,s 50 Fastest-Growing Companies, and ... the national specialty pharmacy has found its niche.  To that ... be honored by SFBJ as the 2017 Power Leader in ... receive his award in October, Bardisa said of the three ...
(Date:9/25/2017)... 25, 2017   Montrium , an industry ... today—from the IQPC Trial Master Files & Inspection ... that EastHORN Clinical Services has selected eTMF ... TMF management. EastHORN, a leading European contract research ... increase transparency to enable greater collaboration with sponsors, ...
Breaking Medicine Technology:
(Date:10/13/2017)... Vegas, Nevada (PRWEB) , ... October 13, 2017 , ... ... 7® Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD ... dose required and providing a CBD form that can be easily incorporated into liquid ...
(Date:10/13/2017)... ... 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes in ... the facility as part of a disaster drill on October 3rd. , Apple Rehab ... City Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for ... for action towards gender equality at their inaugural Summit in New York City in ... reached a social audience of over 3 million. To watch the Mobilize Women video, ...
(Date:10/13/2017)... ... ... Talented host, actor Rob Lowe, is introducing a segment ... of "Success Files," which is an award-winning educational program broadcasted on PBS Member ... with passion and integrity. , Sciatica occurs when the sciatic nerve in the ...
(Date:10/13/2017)... ... 13, 2017 , ... “America On The Brink”: the Christian history of the ... is the creation of published author, William Nowers. Captain Nowers and his wife, ... he spent thirty years in the Navy. Following his career as a naval ...
Breaking Medicine News(10 mins):