Until they were seized, the products were held under embargo by the New Jersey Department of Health and Senior Services at FDA's request.
Under the Federal Food, Drug, and Cosmetic Act, the seized gel is adulterated, because product samples were contaminated with two strains of bacteria, Pseudomonas aeruginosa and Klebsiella oxytoca. The gel is also misbranded because it is dangerous to health when used in the manner suggested in the labeling. These bacteria pose serious risks of infection to individuals exposed to the product.
"This ultrasound gel presented serious health risks to patients, particularly vulnerable ones," said Dara A. Corrigan, the FDA's associate commissioner for regulatory affairs. "Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health."
Ultrasound is an imaging method that uses high-frequency sound waves to produce precise images of structures within the body. Ultrasound transmission gel improves the transmission of the ultrasound waves.
According to the complaint filed in the U.S. District Court for the District of New Jersey, FDA analysis of product samples collected in February 2012 revealed the presence of the two bacterial strains.
The FDA received a report involving 16 surgical patients infected with Pseudomonas aeruginosa. The patients had transesophageal ultrasound procedures, while undergoing heart valve replacement, using Other-Sonic Generic Ultrasound Transmission Gel.
The affected gel products include 250 milliliter and 5 liter containers of Other-Sonic Generic Ultrasound Transmission Gel. The FDA warns health care professionals who perform ultrasound procedures to stop using Other-Sonic Generic Ultrasound Transmission Gel manufactured from June 2011 through December 2011, because of the risks posed by bacteria contamination.
The FDA today issued a safety communication alerting health care providers that bacteria found in non-sterile Other-Sonic Generic Ultrasound Transmission Gel poses risks of infection.
U.S. Marshals, acting at the request of the Food and Drug Administration, have seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J., after an FDA analysis found that product samples contained dangerous bacteria. The seizure included all lots of the gel product manufactured between June 2011 and December 2011.