URGENT ULTRASOUND GEL RECALL
August 26, 2021
This is to inform you of a product recall involving ultrasound gel product, All Eco Med Ultrasound Gels and Lotions and ProAdvantage Ultrasound Gel and Lotion, originally manufactured by Eco-Med Pharmaceutical Inc.
We are instructing you to immediately stop using and discard products listed below due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc).
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs
ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs
ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs
NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs
NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter 4/cs
NDC P301115 ProAdvantage Ultrasound Lotion 5L W/Empty Btl 4/cs
ECO 30GS Ecogel 100 Ultrasound Grn lin X 5L Cube 1 Dispenser Bti
ECO 30GB Ecogel 100 Ultrasound Grn 8.5 oz Btl 24/cs
ECO 50TS Gel Tens Ultrasound lin X 5L cube 1
Health Hazard: The effects of Bcc range from no symptoms to serious infections, including bloodstream infections that may result in sepsis or death. To date, the use of Eco-Med ultrasound gels has been associated with at least 59 infections, including 48 bloodstream infections. Additional possible infections may have been associated with the use of Eco Med ultrasound gels.
Eco-Med initiated a voluntary recall on Aug. 4, 2021, to stop use of EcoGel 200 Ultrasound Gel due to risk of bacterial contamination. However, the FDA has determined that all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.
The FDA’s determination is based on concerns that the company did not complete its investigation of the issues, the root cause and extent of bacterial contamination was not identified, and multiple products could be affected by manufacturing issues associated with the company’s ultrasound gel (such as inappropriate testing of finished product, inadequate testing of raw materials, and a lack of environmental controls).
Eco-Med has shut down all operations and is no longer manufacturing or distributing any products.