U.S. Marshals Seize Unapproved Scar Removal Drug From Crescendo Therapeutics
After a warning letter and two failed inspections, the FDA called in the big guns, requesting that U.S. marshals seize an unapproved, misbranded scar removal drug marketed by Crescendo Therapeutics.
The Vista, Calif.-based company was put on notice in November when the FDA sent it a warning letter for illegally marketing HybriSil (methylprednisolone acetate), a prescription topical corticosteroid, and for doing so without a documented postmarket adverse experience reporting system.
The agency also considers the drug misbranded because its labeling does not contain adequate directions for its intended uses, the November letter states. The violations were discovered during an April 2011 inspection.
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