Policy/Biz

FDA Looks To Shut Down Pharmaceutical Innovations Inc. After Unheeded Warnings About Contaminated Ultrasound Gels

Ultrasound gel
The FDA has asked a court to order a New Jersey maker of ultrasound gels to stop selling its products until it solves ongoing sterility issues. Photo courtesy of Shutterstock

A company in Newark, N.J., has been selling bacteria-laced ultrasound gels that pose risks of infection, the Food and Drug Administration (FDA) reported Friday as it asked a court to shut down the company.

Pharmaceutical Innovations, Inc. manufactures gels used for ultrasound, mammography, and electrocardiogram. But according to the FDA, those gels contained high enough amounts of two pneumonia-causing bacteria (Pseudomonas aeruginosa and Klebsiella oxytoca) that they were putting patients at risk of infection. In April 2012, patients at a Michigan hospital became infected from the gel during surgery. The FDA said the company failed to solve the problem, despite repeated warnings. 

On Thursday, the agency sought an injunction in New Jersey's U.S. District Court to prevent the company "and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements." On Saturday morning, the company's website was still actively marketing its products.

In 2012, U.S. Marshals entered Pharmaceutical Innovations' facilities and seized some of its ultrasound gels after FDA tests discovered the presence of the bacteria. The company released a statement at the time, from Buchalter, decrying the seizure but not denying that there had been a problem. It said that as soon as it learned about the contamination, "all distributors were advised to suspend distribution and return affected lots to the Company." Buchalter said the steps it had taken were "sufficient," adding that this was the first sterility issue since Pharmaceutical Innovations was founded in 1961.

Still, the FDA says the company has been selling products without prior regulatory approval. “Despite multiple warnings by the FDA over the past three years, and promises to correct the numerous ongoing violations, the defendants continued to violate the law,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs, in the news release. “This presents serious health risks to patients who used and continue to use the company’s products. By taking this action, the FDA is demonstrating its commitment to protecting the public from the dangers of adulterated and misbranded medical products.”

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