FDA Seizes Over $15 Million in Unapproved Topical Drugs
U.S. Marshals last week seized more than $15 million in unapproved prescription drugs from a Florida distributor, the FDA now says.
The agency initially reported that the products’ total value was $1.5 million, but that number was released during the early stages of product inventory, FDA spokesman Christopher Kelly said.
The seized products, manufactured by Sonar Products in Carlstadt, N.J., and distributed by Miami-based Stratus Pharmaceuticals, are topical in nature and include antibiotic skin cleansers, wound ointments and analgesic ear drops, among others, the FDA says.
The seizure follows a November and December 2014 inspection of Stratus’ facility, which revealed that the company was marketing the products without FDA-approved drug applications. That discovery resulted in a complaint filed by the U.S. Attorney’s Office in the U.S. District Court for the Southern District of Florida.
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