Navigation Links
U.S. Marshals Seize Auralgan Otic Solution
Date:2/16/2011

SILVER SPRING, Md., Feb. 16, 2011 /PRNewswire-USNewswire/ -- U.S. Marshals, at the request of the U.S. Food and Drug Administration, yesterday seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky.  Auralgan is manufactured for Deston Therapeutics, located in Chapel Hill, N.C., and is warehoused at ICS.  

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Deston's sale of the product in the United States violates federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.  The value of the products seized is estimated to be $16.5 million.

"The FDA is committed to taking enforcement action against companies marketing drugs that do not meet federal standards for safety, effectiveness, and quality," said Deborah M. Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "We will remain vigilant in our efforts to protect consumers from unapproved products."

On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, citing the company for distributing unapproved new drugs and misbranded drugs.  The FDA also warned Deston that Auralgan was an unapproved new drug in April, June, and September 2010, and the company continued distributing the drug in violation of the Federal Food, Drug, and Cosmetic Act.

Today's action is part of the FDA's Unapproved Drugs Initiative, established in 2006 to get unapproved drugs either approved or off the market.

For more information:

February 5, 2010 Warning Letter to Deston Therapeutics, LLC

Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval

Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




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

Related medicine technology :

1. U.S. Marshals Seize Dental Devices From Florida Manufacturer
2. Federal Agents Seize FastSize Extenders and FastSize EQM™ Erectile Quality Monitors
3. Biosites Triage Products Seized by Beijing Customs; Chinese Market Facing Shortage
4. United States Seizes Unapproved Ozone Generators
5. Prime Therapeutics Vice President of Specialty Pharmacy Solutions Speaks at 16th Annual PBMI Drug Benefit Conference
6. Aerotel to Present Mobile Health and Telemedicine Solutions at Mobile World Congress 2011
7. Crucell Shareholders Adopt Offer Governance Resolutions and Johnson & Johnson Makes Announcement on U.S. Regulatory Matters
8. MedShape Solutions, Inc. Announces Breakthrough in ACL Reconstruction
9. Fairleigh Dickinson University Announces Partnership with Medco Health Solutions, Inc. for New School of Pharmacy
10. Cognizant Selected by Lilly to Deliver Commercial Operations Solutions to Enhance Sales and Marketing Effectiveness, Business Performance
11. MMIS, Inc. Launches the MediSpend™ Aggregate Spend Solution
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... 2016  Sequent Medical, Inc. announced today that it ... the safety and effectiveness of the WEB™ Aneurysm Embolization ... aneurysms.  Prof Laurent Spelle , MD, Head of ... France and Principal Investigator of the CLARYS ... and Germany.  Although patients with ruptured aneurysms ...
(Date:2/12/2016)... 12 2016  OMS Supply, a large provider of ... announced today the recent launching of their new company ... of features that enhance the user experience and enable ... --> --> Despite ... company that started in early 2016, they have already ...
(Date:2/11/2016)... NEW YORK , Feb. 11, 2016 ... - Companion Diagnostics in Personalized Medicine and Cancer ... Markets. - High-Growth Diagnostic Testing Markets. - ... Cancer Testing. - Molecular Diagnostics in Genetic Testing. ... - Molecular Diagnostics Markets. - Over-the-Counter Diagnostic Products ...
Breaking Medicine Technology:
(Date:2/13/2016)... CA (PRWEB) , ... February 13, 2016 , ... With ... particle overlays to footage all within Final Cut Pro X. Each user can select ... over 3D rotation, angle of view, blur, focus offset, hue, saturation, value, contrast, glow, ...
(Date:2/13/2016)... Salt Lake City, Utah (PRWEB) , ... February 13, 2016 , ... When an ... kids, Host Parents aren’t always sure what they are in for and they are often ... Pairs are more than they were hoping for. This year’s Au Pair of the Year ...
(Date:2/12/2016)... ... February 12, 2016 , ... Mystic Buddha Publishing House presents Valentine’s Day tips ... biography of Rama - Dr. Frederick Lenz. , According to Publisher Roger ... Buddhist teacher for teaching and helping others. Valentine’s Day celebrates love in all ...
(Date:2/12/2016)... ... ... , Back to the Future , Feb. 25, 2016 — 11:00 a.m. – 12:30 p.m. ... learn from history are doomed to repeat it.” , An analysis of CDRH’s enforcement actions ... takes time. , Take a close look at the warning letters the agency sent ...
(Date:2/12/2016)... ... February 12, 2016 , ... Coco Libre, the maker of coconut water ... LA GRAMMY’s Style Lounge Event. Coco Libre will offer musicians and celebrities the company’s ... big event. The invitation-only gifting suite, held this year at the W Hollywood Hotel, ...
Breaking Medicine News(10 mins):