FDA Warns of Ultrasound Gel Contamination
A large batch of ultrasound transmission gel from Pharmaceutical Innovations Inc. in Newark, NJ has been seized in response to an FDA warning that the gel contained dangerous bacteria.
The FDA issued the report April 18, 2012 after the gel was found to be contaminated with Pseudomonas aeruginosa and Klebsiella oxytoca, which can cause inflammatory dermatitis, pneumonia, wound infection, bloodstream infection, and sepsis.
“At this time, the FDA is concerned about contamination of Other-Sonic Generic Ultrasound Transmission Gel lot numbers 060111 through 120111. These lots contain both 250 milliliter (mL) bottles and 5 liter (L) dispensing containers of gel,” the statement read.
Read the full alert, as well as the press announcement, on the FDA’s site.
-Michael Potts
FDA Safety Communication: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection [press release]. U.S. Food and Drug Administration; April 18, 2012.
U.S. Marshals seize ultrasound gel product at a New Jersey company [press release]. U.S. Food and Drug Administration; April 18, 2012.