2012The Food and Drug Administration has issued a safety communication to warn health professionals to “STOP using Other-Sonic Generic Ultrasound Transmission Gel manufactured June through December 2011 because of bacterial contamination.”
by: ASRM Office of Public Affairs
Published in ASRM Bulletin Volume 14, Number 23
An FDA press release reports, “U.S. Marshals, acting at the request of the Food and Drug Administration, have seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J., after an FDA analysis found that product samples contained dangerous bacteria. The agency reports that at least 16 patients from one hospital were infected with the bacteria.
The contamination was found in lot numbers 060111, 090111, and 120111. These lots are sold in 250 milliliter bottles and 5 liter dispensing containers. The FDA urges health care professionals not to use containers labeled with these numbers and to assess the health of patients who may have been treated with contaminated gel.
Health care 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 at 1-800-332-1088 or to file a report at www.fda.gov/medwatch/report.htm
For further information, please see the text of the FDA’s Safety Communication at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm299409.htm
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