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:8/2/2017)...  Life Flight Network and PeaceHealth Oregon Network announced they ... and operational efficiency for patients at hospitals in ... Cottage Grove , and Florence, Oregon ... Flight Network work collaboratively to move patients who require the ... time sensitive emergency exists. ...
(Date:7/31/2017)... Pharmacy, Inc. (NYSE: DPLO), has been named one of the ... Crain,s Detroit Business . The annual Crain,s Fast ... growth. This year,s edition measures growth from 2013 to 2016. ... list, visit crainsdetroit.com/awards/fast_50/2017 .  "Being named ... Phil Hagerman , CEO and chairman of Diplomat. "We,ve made ...
(Date:7/28/2017)... 2017 Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), ... ended June 30, 2017, and updated its financial outlook ... For the fiscal third quarter, Hill-Rom reported earnings ... diluted share in the prior-year period. These results reflect ... diluted share primarily related to the non-cash write-down of ...
Breaking Medicine Technology:
(Date:8/21/2017)... ... August 21, 2017 , ... Duncan Insurance Agency debuts the ... of Michigan. The new initiative fundraises for the Kalamazoo Humane Society (KHS), which ... animal protection and welfare by addressing the root causes of pet overpopulation. As ...
(Date:8/21/2017)... ... August 21, 2017 , ... San Diego physician and surgeon Dr. James Veltmeyer, ... announced his candidacy for the 52nd Congressional District currently held by Representative Scott Peters. ... to this country at age eleven after suffering homelessness and hardship in a distant ...
(Date:8/20/2017)... ... August 20, 2017 , ... HIPAA ... Management System has assisted multiple clients in successfully passing audits such as ... Control Level 2 (AICPA SOC Level 2), and State Data Use Agreement Audits. ...
(Date:8/19/2017)... (PRWEB) , ... August 18, 2017 , ... Western University ... health and education to launch the University’s new Center for Innovation on Wednesday, September ... Health Education Center Lecture Hall 1, followed by a technology exhibition from 1 to ...
(Date:8/19/2017)... ... August 19, 2017 , ... Curl Keeper® is excited ... The Curl Leaders, Editors’ Choice 2017 Award for the second year in a row. ... stylists and curlies alike was voted Best Moisturizer for Type 2 Wavies and Best ...
Breaking Medicine News(10 mins):