Permanent injunction against New Jersey drug manufacturer and its president to stop distribution of unapproved drugs

The U.S. District Court for the District of New Jersey entered a consent decree of permanent injunction against Acino Products LLC, of Hamilton, New Jersey, and its president, Ravi Deshpande, to prevent the distribution of unapproved and misbranded drugs, the Department of Justice announced today. 

Acino manufactures and distributes hydrocortisone acetate suppositories under the brand names Rectacort-HC and GRx HiCort 25.  Deshpande is Acino’s president and is responsible for, and has authority over, all operations at the firm. 

The department filed a complaint in the U.S. District Court for the District of New Jersey at the request of the U.S. Food and Drug Administration (FDA), alleging that the company’s suppositories 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 that prohibits them from committing violations of the federal Food, Drug and Cosmetic Act.  The consent decree 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 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.

“Companies that manufacture and distribute drugs must comply with FDA regulations,” said FDA Associate Commissioner Melinda Plaisier of 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 FDA has conducted at least three inspections of the facility between Feb. 6, 2014, and March 5, 2014; Aug. 7, 2014, and 19, 2014; and Jan. 12, 2015, and 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.