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
“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
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.
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