FDA: U.S. Marshals seize contaminated ultrasound gel from N.J. plant

FDA: U.S. Marshals seize contaminated ultrasound gel from N.J. plant

April 20th, 2012 // 12:51 pm @

U.S. Marshals have raided a New Jersey plant that produces ultrasound transmission gel at the request of the the U.S. Food and Drug Administration after the agency found product samples contained dangerous bacteria.

Product lots of Other-Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc. in Newark, N.J, were seized by marshals because they contained two bacteria strains that may cause infection, Pseudomonas aeruginosa and Klebsiella oxytoca.

Millions of American men and women undergo an ultrasound diagnostic test that uses high-frequency sound waves to produce images of structures inside the body. Many women especially will undergo an ultrasound to check the baby’s health throughout pregnancy. The gel helps amplify the transmission of the ultrasound waves.

According to the FDA, 16 patients undergoing heart valve replacement surgery who were given this particular brand of gel for a procedure called a “transesophageal ultrasound” (that looks at the heart and blood vessels) became infected with Pseudomonas aeruginosa.

“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”

The FDA has also issued a safety alert to health care providers that bacteria found in non-sterile Other-Sonic Generic Ultrasound Transmission Gel poses risks of infection. Seized lots were made between June and December 2011, according to the FDA.

According to Medscape Reference, infections from Pseudomonas frequently lead to pneumonia, urinary tract infections, and bacteremia.

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