The FDA informs that US Marshals have seized Other-Sonic Generic Ultrasound Transmission Gel after laboratory analyses found samples contained two strains of bacteria, Pseudomonas aeruginosa and Klebsiella oxytoca. The gels were seized from Pharmaceutical Innovations Inc. in Newark, New Jersey, and included lots manufactured between June 2011 and December 2011 (all lots).
The gels had been held under embargo by the NJ Department of Health and Senior Services, the FDA (Food and Drug Administration) wrote today.
The gels are adulterated, according to the Federal Food, Drug, and Cosmetic Act. The labeling is faulty too, according to the FDA. If they are used according to labeling instructions, they could pose a danger to health.
The FDA, in a communiqué today, wrote:
” These bacteria pose serious risks of infection to individuals exposed to
the product.”
Dara A. Corrigan, Associate Commissioner for regulatory affairs, FDA, said:
“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones. Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”
Ultrasound transmission gel enhances the transmission of ultrasound waves. Ultrasound uses high-frequency sound waves to produce images of structures within the body.
16 reports of surgical patients infected with Pseudomonas aeruginosa have been received by the FDA. They had all undergone transesophageal ultrasound procedures while undergoing heart valve replacement. Other-Sonic Generic Ultrasound Transmission Gel was used on all of them.
Health care professionals who perform ultrasounds have been told by the FDA to stop using the above-mentioned gel, manufactured from June 2011 to the end of December 2011. They are presented in 250 milliliter and 5 liter containers.
The following lot numbers were found to be contaminated:
- 060111
- 090111
- 120111
Written by Christian Nordqvist