FDA warns of contaminated ultrasound gel

April 26, 2012

FDA has issued a warning to healthcare professionals that exposure to a contaminated generic ultrasound gel may result in bacterial infection.

FDA has issued a warning to physicians that exposure to a contaminated generic ultrasound gel may result in bacterial infection.

All lots of the 250-mL and 5-L containers of Other-Sonic Generic Ultrasound Transmission Gel produced between June and December 2011 are affected by the warning.

In a Safety Communication dated April 18, FDA is warning healthcare professionals to stop using Other-Sonic Generic Ultrasound Transmission Gel (Pharmaceutical Innovations Inc, Newark, NJ) made between June and December 2011 because it poses serious risks of infection to those exposed to it.

Opened and unopened containers should be handled as biohazards and disposed of accordingly. Specifically implicated were the 250-mL and 5-L containers of the non-sterile, water-soluble contact medium with lot numbers 060111, 090111, and 120111.

Healthcare professionals are requested to identify patients exposed to the product, to review the procedures they underwent and the outcomes of those procedures, and to determine whether further evaluation is necessary.

At the request of the US Food and Drug Administration (FDA), federal marshals seized all lots of the product at Pharmaceutical Innovations’ facilities after analysis revealed the product had been contaminated with Pseudomonas aeruginosa and Klebsiella oxytoca, according to an FDA news release issued April 18.

The investigation was triggered by a hospital report involving 16 surgical patients who had transesophageal ultrasound procedures using the gel while undergoing heart valve replacement surgery and became infected with P. aeruginosa.

Contact Pharmaceutical Innovations at 973-242-2900 with questions and to report adverse events associated with the use of the contaminated gel. Report adverse events through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

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