DOJ Enters Consent Decree Against Acino Products

The US District Court for the District of New Jersey has entered a consent decree of permanent injunction against Acino Products LLC, of Hamilton, NJ, and its president, Ravi Deshpande, to prevent the distribution of unapproved and misbranded drugs, the Department of Justice (DOJ) announced in a press statement on July 1. 

The DOJ filed a complaint at the request of FDA alleging that the company’s hydrocortisone acetate suppositories-marketed under the brand names Rectacort-HC and GRx HiCort 25-are not approved by the FDA and that they are misbranded because they do not bear adequate directions for use as required by law. 

In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction requires the drug manufacturer to cease all manufacture and distribution of the unapproved and misbranded suppositories, and to destroy any such suppositories already in existence.

The FDA has conducted at least three inspections of the facility between Feb. 6–March 5, 2014; Aug. 7–19, 2014; and Jan. 12–25, 2015.

According to the complaint, during the February/March 2014 inspection, FDA investigators documented the company’s manufacturing of hydrocortisone acetate suppositories on behalf of Ascend Laboratories LLC.  The complaint alleges that at the conclusion of the inspection, Deshpande indicated that he was aware that the suppositories were being marketed by Ascend as prescription drugs without FDA approval.    

In May 2014, the government conducted a seizure of certain unapproved and misbranded drugs that were being distributed by Ascend, including suppositories that Acino had manufactured for Ascend.  The government notified Acino and Deshpande of the seizure by a letter dated May 15, 2014.  According to the complaint, the letter made clear that the suppositories were unapproved and misbranded drugs, however, Acino and Deshpande continued to manufacture the products. 

According to the complaint, at the conclusion of the August 2014 and January 2015 inspections, FDA investigators again discussed the unapproved status of the hydrocortisone acetate 25-mg suppositories with Deshpande, who indicated that he was aware of the need to pursue FDA approval for the drug.  As alleged in the complaint, to date, Acino and Deshpande have not filed the necessary application with the FDA to gain approval for the unapproved drug products, DOJ reports in the press statement.

Source: US Department of Justice