FDA Confiscates Unapproved Drugs Worth $11 Million From Ohio Distributor

May 19, 2014, 9:53 PM UTC

More than $11 million in “unapproved and misbranded” drugs marketed by Ascend Laboratories have been seized by U.S. marshals, at the request of the Food and Drug Administration.

Ascend’s confiscated products taken from its distributor, Masters Pharmaceuticals of Cincinnati, haven’t been proven safe or effective for their intended uses, the FDA said May 16.

Chief among the seized products are pramoxine-HC otic drops, intended to treat external ear infections; hydrocortisone acetate suppositories 25 mg, intended to treat inflamed hemorrhoids, ulcerative colitis and other inflammatory conditions; and urea cream 39 percent, urea cream 40 percent and urea lotion 40 percent, intended ...

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