US Marshals Seize Unapproved Drugs

FDA announced on April 16, 2015 that US Marshals have seized more than $1.5 million of unapproved prescription drugs from Stratus Pharmaceuticals, a Miami-based distributor. The drugs were manufactured by Sonar Products of Carlstadt, NJ. The Marshals seized the drugs at the request of FDA and the US Attorney for the Southern District of Florida.

Following an FDA inspection conducted in late 2014, the US Attorney’s Office filed a complaint on behalf of FDA. The agency had discovered during the inspection that the company had been marketing drug products without FDA-approved drug applications. FDA states that the “products have not been proven safe and effective for their intended uses.”

“Companies that market unapproved drugs are placing consumers at risk because the products may not be safe, effective or made using quality manufacturing practices,” said Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a press release. “The FDA is committed to protecting consumers and will continue to take actions against companies that do not meet these standards.”

Products seized included a solution used to treat excessive sweating, an antibiotic skin cleanser, topical skin ointments to treat wounds and skin conditions, and analgesic ear drops. According to FDA, seizure of the products “is consistent with the enforcement policy set forth in the FDA’s Marketed Unapproved Drugs Compliance Policy Guide, which, among its other provisions, provides notice that any product that is being marketed illegally and the persons responsible for causing the illegal marketing of the product are subject to FDA enforcement action at any time.”