NOTICE – EcoVue® Ultrasound Gel Unaffected by FDA Recall
Recalled Product Eco-Gel 200 Ultrasound Gel Manufactured by Eco-Med Pharmaceutical, Inc., Has No Connection to HR Pharmaceuticals, Inc.
The recent recall of ultrasound gel manufactured in Canada by Eco-Med Pharmaceutical, Inc., is NOT related to EcoVue Ultrasound Gel or any other product of HR Pharmaceuticals, Inc.
Your organization may have been informed about a recall of ultrasound gel due to contamination with the Burkholderia cepacia bacterial complex after the use of ultrasound gel from Eco-Med Pharmaceutical, Inc., were associated with at least 15 infections, including bloodstream infections. Rest assured, the ultrasound gel in question is NOT EcoVue Ultrasound Gel or any other product of HR Pharmaceuticals, Inc.
EcoVue Ultrasound Gel and other HR Pharmaceuticals, Inc. products are not under any recalls and remain safe for continued use.
EcoVue Ultrasound Gel is manufactured in the United States by HR Pharmaceuticals, Inc., at a cGMP compliant, ISO 13485:2016 and MDSAP certified facility under the strictest quality control/infection control guidelines, and has undergone extended usability testing and complies with USP standards for Antimicrobial Effectiveness.
We understand that similarities in product brand names may sometimes cause confusion. If you have questions about this announcement or the exemplary quality control and safety record of products of HR Pharmaceuticals, Inc., please contact me at your convenience.
Chris P. Wiesman
Chief Revenue Officer