U.S. Marshals Service raids the offices of an ultrasound gel manufacturer
FDA: The gel contains dangerous amounts of bacteria that has sickened 16 patients
Pharmaceutical Innovations Inc. of New Jersey is the manufacturer
The U.S. Marshals Service raided the offices of an ultrasound gel manufacturer on Wednesday, seizing the product that the Food and Drug Administration said contains dangerous amounts of bacteria that has sickened 16 patients.
New Jersey-based Pharmaceutical Innovations Inc. manufactures Other-Sonic Generic Ultrasound Transmission Gel. The gel is used by medical professionals in ultrasounds, a procedure involving high-frequency sound waves to look at patients’ organs. Samples of the gel taken by the FDA in February contained two strains of bacteria.
“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” the FDA’s Dara Corrigan said in a statement. Additionally, the FDA issued a safety alert to health care providers about the bacteria risk and possibility of dangerous infections from the gel.
A person answering the phone at Pharmaceutical Innovations Inc. told CNN that the president of the company was unavailable and the company had no other comment.
According to a spokesman for the Marshals Service, the FDA asked for federal law enforcement assistance as a safety precaution.
Pharmaceutical Innovations’ website claims it is the “world’s leader in ultrasound contact media.”
A photo on the website shows company executives with President George W. Bush in the White House Oval Office celebrating a 2007 award for the company’s contributions to U.S. exports.