Johnson City, Tenn.-based Crown Laboratories must halt the manufacturing and distribution of various prescription and over-the-counter skin creams following a complaint filed by the Department of Justice on behalf of the Food and Drug Administration.
The complaint alleged Crown Laboratories violated the federal Food, Drug, and Cosmetic Act by manufacturing and selling unapproved skin products intended to treat various dermatological illnesses, including eczema, psoriasis and keratosis.
Under a consent decree, Crown Laboratories must stop all operations related to these drugs until they receive FDA approval. The drugmaker must also give the FDA written notice within 20 days of a court order that it is prepared to destroy all unapproved skin products.
"The public has a right to assume that drugs in the marketplace are safe, effective, have obtained proper approvals and are labeled with the information necessary to allow for proper use," said Chad Readler, acting assistant attorney general of the Justice Department's Civil Division. "Where drug manufacturers violate these fundamental requirements, the Department of Justice will continue to work aggressively with the FDA to ensure that the pharmaceutical industry follows the rules. Doing so is necessary to protect American consumers."