The FDA released a memo informing health care providers, health care facility risk managers, and procurement staff to immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc., due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). 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.
The FDA recommends that health care providers and facilities:
- Immediately stop using and discard all ultrasound gel and lotion products manufactured by Eco-Med.
- Do not purchase ultrasound gels or lotions manufactured by Eco-Med.
- Consult Centers for Disease Control and Prevention (CDC) and professional society guidelines regarding use of ultrasound gel and appropriate ultrasound cleaning procedures (see Additional Resources).
- Contact the distributor that supplied these products to you if you have questions about the disposal of the products.
- Report any adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program.
Additional information from FDA’s memo may be found here.
Additional information from CDC on the ongoing investigation may be found here.
If health care facilities identify infections from Burkholderia cepacia complex or Burkholderia stabilis, associated with use of Eco-Med Pharmaceutical products, facilities should inform their county health department who can then involve the HAI Prevention Program for further investigation and support.