Permanent Injunction Issued Against Drug Manufacturing Company

A federal judge has entered a consent decree of permanent injunction against a manufacturing company for marketing unapproved and misbranded prescription drugs.

The US Department of Justice, on behalf of the FDA, entered the decree against Acino Products LLC, based in New Jersey, and the company president, Ravi Deshpande.

According to an FDA press release, Acino allegedly marketed hydrocortisone acetate 25 milligram suppositories under the brand names Rectacort-HC and GRx HiCort 25 to treat conditions such as inflamed hemorrhoids and chronic ulcerative colitis.

Neither Rectacort-HC, nor GRx HiCort 25 have been approved by the FDA. The labeling of these 2 drugs also do not have adequate directions for use, the FDA maintained.

Even after several warnings from the FDA about manufacturing and distributing unapproved new drugs, Deshpande and his company continued to make and ship the unapproved products, according to the complaint.

As part of the consent decree, Acino will be required to stop distributing hydrocortisone acetate 25 milligram suppositories and any other unapproved prescription drugs. The company will also have to destroy its supply of the suppositories.

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