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.

The U.S. Department of Justice brought the action on behalf of the U.S. Food and Drug Administration.

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.

“Companies that manufacture and distribute drugs must comply with FDA regulations,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “Acino repeatedly violated federal law through their actions. We must continue to oversee manufacturers to ensure that patients have access to safe and effective approved drugs.”

“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, head of the Department of Justice’s Civil Division.

According to the complaint, FDA investigators inspected the Acino facility in March 2014, August 2014, and January 2015.  During the inspections, the FDA warned Acino about continuing to manufacture and distribute unapproved new drugs. At the conclusion of the March 2014 inspection, 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.

At the conclusion of the August 2014 and January 2015 inspections, FDA investigators again discussed the unapproved status of these products with Mr. Deshpande. However, Acino continued manufacturing and distributing the unapproved new drug products.

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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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