N.J. Drugmaker Ordered to Destroy Product, Quit Manufacturing
A federal judge in New Jersey ordered a Hamilton, N.J., company charged with marketing unapproved and misbranded suppositories to destroy its stock and discontinue manufacturing the products.
Acino Products marketed unapproved prescription hydrocortisone acetate suppositories under the brand names GRx HiCort 25 and Rectacort-HC to treat medical conditions such as inflamed hemorrhoids, chronic ulcerative colitis and other inflammatory ailments. In addition to not having FDA approval, the suppositories’ labels listed inadequate directions for use.
During a March 2014 inspection, FDA investigators documented that Acino shipped unapproved suppositories on behalf of another New Jersey drugmaker, Ascend Laboratories. The agency warned Acino and seized the shipment.
In subsequent August 2014 and January 2015 inspections, the FDA again discussed the products with the firm’s president, Ravi Deshpande. Despite those conversations, Acino continued to manufacture and distribute the suppositories, leading to the court action.
Acino Products and Ascend Laboratories did not respond to requests for comment by press time.
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