Unapproved Prescription Drugs Seized by US Marshals

US Marshals have seized $1.5 million worth of unapproved prescription drugs from Stratus Pharmaceuticals at the request of the FDA and the US attorney for the Southern District of Florida.

The Miami-based company had marketed and distributed unapproved products made by Sonar Products, located in Carlstadt, New Jersey.

According to an FDA press release, the seized products include a solution used to treat excessive sweating; an antibiotic cleanser for treatment of skin conditions; a topical ointment used to treat wounds; a topical cream and gel to treat psoriasis, eczema, and other skin conditions; and analgesic ear drops.

As these products have not been proven safe and effective for their intended use, patients who bought these items should consult a health care professional or pharmacist about choosing a different treatment option, the FDA advised.

“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.”

A FDA inspection in November and December 2014 uncovered Stratus was marketing the products without FDA-approved drug applications. The US attorney’s office also filed a complaint on behalf of the FDA that the products were not approved under Federal Food, Drug, and Cosmetic Act regulations.