The agency notified health care professionals and facilities to stop their use of Other‐Sonic Generic Ultrasound Transmission Gel.
The contaminated gel was manufactured from June 2011 though December 2011. The contamination was discovered in the following lots, which are sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers: 060111, 090111, and 120111.
The two bacteria involved are Pseudomonas aeruginosa and Klebsiella oxytoca.
Pseudomonas aeruginosa is typically found in water and soil. Patients exposed to this bacterium on their skin’s surface could develop inflammatory dermatitis, even on intact skin.
The Klebsiella bacterium is typically found in the digestive tract where they do not generally cause infection; however, when the lungs or other tissues are exposed to the Klebsiella bacterium, either minor problems or more serious infections, such as pneumonia, wound infection, or bloodstream infections, can occur.
Other‐Sonic Generic Ultrasound Transmission Gel is manufactured by Pharmaceutical Innovations Inc. and is a nonsterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
According to CNN, the U.S. Marshals Service raided Pharmaceutical Innovations Inc. offices’, seizing its Other‐Sonic Generic Ultrasound Transmission Gel. A spokesman for the Marshals Service told CNN that the agency asked for federal law enforcement assistance as a safety precaution. “This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” FDA’s Dara Corrigan said in a statement.
Attempts to reach Pharmaceutical Innovations Inc., which describes itself on its web site as the “world’s leader in ultrasound contact media,” were not successful, said CNN. A person answering CNN’s call there told the news outlet that the company’s president was not available and that Pharmaceutical Innovations Inc. had no other comment.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Online at www.fda.gov/MedWatch/report.htm. Or, download the form at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm or call the FDA, toll-free, at 1.800.332.1088 to request the form. Return the form to the address on the preaddressed form or submit the form, by fax, to 1.800.FDA.0178.