NEWARK, N.J. (Legal Newsline) — The Department of Justice has announced a settlement with Pharmaceuticals Inc., based in Newark, after allegations the company distributed ultrasound gel contaminated with bacteria.
“The sale of adulterated medical devices puts patients at great risk,” said principal deputy assistant attorney general Benjamin C. Mizer, head of the Justice Department’s Civil Division. “Device manufacturers that fail to comply with good manufacturing practices, thereby threatening patient safety, will be held accountable.”
The defendants agreed to forfeit and destroy the ultrasound gels in question and allow independent experts and auditors to conduct regular assessments of the company’s products. Pharmaceuticals Inc. will additionally pay $100,000 in fines and fees and go under probation for two years.
“Pharmaceutical Innovations shipped defective products that exposed hospital patients to dangerous bacterial contamination,” said U.S. Attorney Paul J. Fishman for the District of New Jersey. “Today’s plea agreement and civil settlement require Pharmaceutical Innovations to accept responsibility for the contamination and take the necessary steps to prevent it from happening again.”
Acting special agent in charge Jeffrey Ebersole of the Food and Drug Administration handled the case.