FDA MedWatch – Eco-Gel 200 by Eco-Med Pharmaceutical: Recall

TOPIC: Eco-Gel 200 by Eco-Med Pharmaceutical: Recall – Due to Bacterial Contamination

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: Eco-Med Pharmaceuticals initiated this recall and quarantine due to bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacia complex (Bcc).

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The ultrasound gels are non-sterile and not indicated for sterile procedures.  Potential routes of transmission leading to bloodstream infections associated with a contaminated nonsterile gel may have included the use of the gel for visualization prior to, in preparation for, or during an invasive procedure or application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance.  

RECOMMENDATIONS: 

Health 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:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.