According to an FDA
press release, the agency asked the U.S. Marshals to seize specified lots of Other-Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc.
The facility is located in Newark, N.J.
This type of gel is used in conjunction with
ultrasound imaging. The FDA decided to take the product out of circulation after it found bacteria in product samples that were collected in Feb. 2012.
The FDA is confiscating all lots of Other-Sonic Generic Ultrasound Transmission Gel that were manufactured between June 2011 and Dec. 2011. The product was found to be contaminated with what was described by the agency as two "dangerous" strains of bacteria,
Pseudomonas aeruginosa and
Klebsiella oxytoca. Additionally, the agency said the gel is misbranded and unsafe when used "in the manner suggested in the labeling."
“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs in the press release. “Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”
Prior to the U.S. Marshals seizing the gel product, the FDA requested the New Jersey Dept. of Health to hold the items under embargo.
FDA is warning medical personnel to cease using Other-Sonic Generic Ultrasound Transmission Gel manufactured in the noted date range due to health risks the product poses. The agency issued a
safety alert to hospitals, doctors and other medical-related offices and businesses. In the alert, the FDA provided medical professionals with the affected lot numbers and product packaging descriptions, and also contains a section entitled "Summary of Problem and Scope" to outline the issues.
Sixteen people have reportedly developed health issues related to the bacteria contained in the ultrasound gel, either experiencing an infection or a colonization of bacteria.
