All lots of an ultrasound gel product of Pharmaceutical Innovations Inc., manufactured between June 2011 and December 2011, have been seized by the U.S. Marshals, acting at the request of the FDA, as the product samples have been found to be adulterated.
The product, known as "Other-Sonic Generic Ultrasound Transmission Gel", is used in the imaging method - Ultrasound, to improve transmission of ultrasound waves.
The ultrasound gel is contaminated with two strains of bacteria, Pseudomonas aeruginosa and Klebsiella oxytoca, which pose risks of infection, and is also misbranded because it is dangerous to health when used in the manner suggested in the labeling, the FDA said in a statement.
There have been reports of 16 surgical patients infected with Pseudomonas aeruginosa who have had transesophageal ultrasound procedures, while undergoing heart valve replacement, using Other-Sonic Generic Ultrasound Transmission Gel.
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