Other safety alerts
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| The United States: Federal judge approves FDA consent decree with Ascend Laboratories |
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A federal judge from the US District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories, LLC, of Montvale, New Jersey on Oct. 10. The US Department of Justice filed the consent decree on behalf of the US Food and Drug Administration.
The consent decree requires Ascend Laboratories to post bond for the release of their unapproved drug products seized by U.S. Marshals in May 2014, which the company is then responsible for destroying under the FDA’s supervision. The drugs were seized at a warehouse in Cincinnati operated by Masters Pharmaceutical, Inc. (doing business as RXTPL).
In addition, the consent decree prohibits Ascend Laboratories and all other associated persons who act in concert with the company from manufacturing and distributing unapproved drugs until the company obtains FDA approval, including: Pramoxine-HC Otic Drops; Hydrocortisone Acetate Suppositories 25 milligrams; Urea Cream 39%; Urea Cream 40%; and Urea Lotion 40%.
The FDA inspected Ascend Laboratories’ New Jersey facility in November 2013 and Masters Pharmaceutical’s Cincinnati warehouse in February 2014. The inspections revealed that Ascend Laboratories was marketing drug products without FDA approval and adequate directions for use.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/../ucm418867.htm
In Hong Kong, there is no registered pharmaceutical product manufactured by Ascend Laboratories, LLC nor by Masters Pharmaceutical, Inc.
Ends/ Wednesday, October 15, 2014
Issued at HKT 12:30
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