FDA recall: The U.S. Department of Justice has moved to shut down a Newark company producing ultrasound gel that was traced to infections in 16 patients.
Working on behalf of the Food and Drug Administration, the DOJ filed a complaint against Pharmaceutical Innovations and its president, Gilbert Buchalter, on Oct. 3 seeking an injunction requiring operations at the plant to cease until it is brought into compliance with federal regulations.
The federal government said Pharmaceutical Innovations produced gel used in ultrasound tests without complying with proper manufacturing practices, failed to obtain proper clearance before distributing its products, and failed to report injuries associated with the products, all in violation of the Federal Food, Drug and Cosmetic Act.
The company makes gels for ultrasound, mammography and electrocardiogram procedures, as well as scanning pads and sprays.
The DOJ seeks an order directing Pharmaceutical Innovations to cease manufacturing and distributing any products until its methods, facilities and controls are brought into compliance with federal regulations and are found acceptable by the FDA.
