Maker of Suppositories Enjoined from Production

(CN) - A Hamilton, New Jersey based firm has been permanently enjoined from manufacturing suppositories after investigators found it was distributing the product without Food and Drug Administration approval.

Under the terms of the consent decree approved by U.S. District Judge Peter Sheridan on Tuesday, Acino Products must destroy all of the hydrocortisone suppositories in its possession within the next 20 days, and reimburse the FDA for the cost of multiple inspections and ongoing monitory.

In a complaint filed on June 5, the government claimed the company and its president, Ravi Deshpande, knowingly manufactured the suppositories for a third party, Ascend Laboratories, despite the fact no one had bothered to apply for FDA approval for the prescription product.

The suppositories were then sold under the brand names Rectacort-HC and GRxHiCort.

Prosecutors said investigators visited the company's facilities on three occasions since February 6 2014, and each time documented the production of the unlawful suppositories.

They also discovered that the products were not appropriately labeled.

In May 2014, the government seized an unspecified number of the suppositories and informed Acino and Deshpande in writer that the products were unapproved and misbranded drugs. Despite receiving this notice, the company continued to manufacture the suppositories.

Representatives of Acino Products could not be reached for comment Wednesday morning.

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