FDA: Tennessee company sold unapproved dermatology products
WASHINGTON — A permanent injunction has been filed against a Tennessee-based company after they were accused of misbranding and distributing drugs not approved by the U.S. Food and Drug Administration.
According to a release from the Department of Justice, Crown Laboratories Inc. sold dermatology creams claiming to treat conditions such as dry skin, xerosis, ichthyosis, skin cracks, dermatitis, exzema and psoriasis.
The FDA said they did not approve the products, nor have they shown sufficient evidence to suggest they are safe.
Those products include Rea Lo (Urea 40 percent) Cream, Rea Lo (Urea 40 percent) Lotion, Rea Lo 39 (Urea 39 percent) Cream, Dermasorb XM Complete Kit (Urea 39 persent cream and moisturizer), and Sodium Sulfacetamide 10 percent and Sulfur 5 percent (Sodium Sulfacetamide).
“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 Acting Assistant Attorney General Chad Readler of the Justice Department’s Civil Division.
Crown has agreed to settle the case and to stop manufacturing the products until they have submitted an application with the FDA and it is approved.
They must also provide a written notice stating they are willing to destroy all of the drugs to the FDA within 20 days.