FDA forces Carlstadt company to shut down

CARLSTADT — The U.S. Food and Drug Administration shut down Sonar Products Inc., accusing the company of manufacturing unapproved pharmaceutical skin products. A consent decree was reached with Sonar and a distributor of the products, Stratus Pharmaceuticals Inc. of Miami, on Thursday, the FDA said in a statement.

The products included dermatological washes, creams and ointments that did not have approval by the FDA, the statement says. Stratus and Sonar routinely shipped unapproved, misbranded and substandard or contaminated drugs, the FDA says.

“These companies have endangered the public by selling products that have not been proven to be safe or effective and are poorly made,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The agency will continue to take aggressive enforcement action against those who repeatedly violate the law and put consumers at risk.”

The consent decree of permanent injunction was entered by U.S. District Judge Kathleen M. Williams for the Southern District of Florida. It also names two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch.

Read more: http://www.northjersey.com/story/news/2017/06/18/fda-forces-carlstadt-company-shut-down/406974001/