Other safety alerts
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| The United States: Federal judge enters permanent injunction against Acino Products, LLC |
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A federal judge for the District of New Jersey has entered a consent decree of permanent injunction between the United States and Acino Products LLC (Acino), of Hamilton, New Jersey, and the company's president, Ravi Deshpande, for marketing unapproved and misbranded prescription drugs.
According to the complaint, Acino marketed unapproved prescription drugs, hydrocortisone acetate 25 mg suppositories under the brand names Rectacort-HC and GRx HiCort 25, for treatment of medical conditions including inflamed hemorrhoids, chronic ulcerative colitis, and other inflammatory conditions. Rectacort-HC and GRx HiCort 25 have not been approved by the FDA. In addition, these prescription drugs are misbranded because their labeling fails to carry adequate directions for use. Unapproved new drugs and misbranded drugs have not been shown to be safe and effective, may be of uncertain quality, and may pose risks to patients.
FDA investigators documented that Acino shipped in interstate commerce unapproved hydrocortisone acetate 25 mg suppositories on behalf of Ascend Laboratories LLC, which were subsequently seized in May 2014.
Under the terms of the consent decree, Acino is prohibited from introducing into interstate commerce unapproved prescription drugs, including hydrocortisone acetate 25 mg suppositories. Acino must also destroy, under FDA supervision, all hydrocortisone acetate 25 mg suppositories in their custody, control or possession.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/../ucm453466.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Thursday, July 02, 2015
Issued at HKT 16:30
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