Decree Orders NJ Company Not to Distribute Unapproved Drugs
FDA said the company's suppositories are not approved by the FDA and are misbranded because they do not bear adequate directions for use as required by law.
The U.S. Department of Justice announced that a federal judge in New Jersey has entered a consent decree of permanent injunction against Acino Products LLC, of Hamilton, N.J., and its president, Ravi Deshpande, to prevent them from distributing unapproved and misbranded drugs. The company manufactures and distributes hydrocortisone acetate suppositories under the brand names Rectacort-HC and GRx HiCort 25, according to DOJ, which filed a complaint at the request of the U.S. Food and Drug Administration.
FDA said the company's suppositories are not approved by the FDA and are misbranded because they do not bear adequate directions for use as required by law. The defendants agreed to settle the litigation and be bound by the consent decree, which prohibits them from violating the federal Food, Drug and Cosmetic Act. They agreed to stop making and distributing them and to destroy any existing suppositories.
"The department will not hesitate to bring enforcement actions against manufacturers who do not follow the necessary procedures to comply with our nation's drug safety laws," said Principal Deputy Assistant Attorney General Benjamin C. Mizer, who heads DOJ's Civil Division.
FDA conducted inspections of the Acino Products facility between Feb. 6, 2014, and March 5, 2014; Aug. 7 and 19, 2014; and Jan. 12 and 25, 2015.