Regulatory Focus™ > News Articles > Manufacturer Raided by US Marshals Service After FDA Finds Contaminated Ultrasound Gel

Manufacturer Raided by US Marshals Service After FDA Finds Contaminated Ultrasound Gel

Posted 19 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) issued a safety communication on 19 April warning consumers about the risks associated with Other-Sonic Generic Ultrasound Transmission Gel after it found bacteria in the gel.

The safety communication came after the US Marshals Service raided the offices of the manufacturer, New Jersey-based Pharmaceutical Innovations, after the firm's product was connected with adverse events in 16 patients across the country.

CNN reports the gel is "used by medical professionals in ultrasounds, a procedure involving high-frequency sound waves to look at patients' organs."

FDA Associate Commissioner for Regulatory Affairs Dara Corrigan said in a statement the gel represented "serious health risks to patients, particularly vulnerable ones."

"FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health," added Corrigan.


Read more:

FDA Safety Communication: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection

CNN - U.S. marshals seize ultrasound gel that allegedly sickened 16 patients

Fierce Pharma Manufacturing - U.S. Marshals seize ultrasound gel containing dangerous levels of bacteria


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe