NJ company faces charges for marketing, misbranding unapproved medications

The U.S. Department of Justice has brought action against Acino Products LLC, and the company’s president, Ravi Deshpande, on behalf of the FDA, for marketing and misbranding unapproved prescription medications.

On Wednesday, a New Jersey federal judge entered a consent decree of permanent injunction between the U.S. and Acino, according to a press release.

“Companies that manufacture and distribute drugs must comply with FDA regulations. 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,” Melinda Plaiser, FDA associate commissioner for regulatory affairs, said in a press release.

The company has been marketing Rectacort-HC and GRx HiCort 25, which are both hydrocortisone acetate 25-mg suppositories, neither of which have been approved by the FDA, according to a press release. Additionally, the medications, which are used for the treatment of inflamed hemorrhoids, chronic ulcerative colitis and other inflammatory conditions, did not provide proper usage instructions.

The Acino facility was inspected by FDA investigators in March 2014, August 2014 and January 2015, and received warnings at all three visits regarding the manufacturing and distribution of unapproved medications.

According to the release, Acino has been ordered to destroy all their hydrocortisone acetate 25-mg suppositories, under FDA supervision. In addition, Acino is not permitted to introduce any unapproved prescription medications into interstate commerce.

“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,” Benjamin C. Mizer, principal deputy assistant attorney general, head of the Department of Justice’s Civil Division, said in the release.