KAWARTHA LAKES-Health Canada is advising Canadians to stop using and discard all products manufactured by Eco-Med Pharmaceuticals (ultrasound gels, transmission and massage lotions, hand sanitizers and first aid antiseptics) due to potential bacterial contamination with Burkholderia stabilis (B. stabilis).
Health Canada previously communicated the manufacturer’s voluntary recall for certain lots of ultrasound gels as a result of this contamination. The Department is now expanding the list of impacted products to include all of the company’s products because the source of the bacterial contamination is unknown and cannot be determined at this time.
Health Canada has suspended the company’s licences to manufacture and sell health products based on potential safety issues. In addition, the Department is not able to determine if there are other potential risks or other bacterial contamination as Eco-Med has ceased all company operations.
B. stabilis is a member of a group of bacterial organisms called Burkholderia cepacia complex (Bcc) that are potentially highly virulent and multi-drug resistant. The effects of Bcc vary widely, ranging from no symptoms at all to serious infections. Bcc bloodstream infections may result in sepsis and death in some cases.
Patients – particularly those with compromised immune systems – experiencing an unusual or persistent infection on the skin or in the general area where the product was applied, or who are feeling unwell (e.g., have a fever and/or feel tired), should seek immediate medical attention.
Product List:
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Medical Devices: massage lotions and ultrasound lotions |
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EcoGel 100 |
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EcoGel 200 |
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EcoGel 300 |
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EcoLotion Transmission and Massage Lotion |
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Medelco Multi Purpose Ultrasound Gel |
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Red Medical Ultrasound Gel |
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Natural Health Products: hand sanitizers and first aid antiseptic |
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Prevent+ (NPN 80097875) |
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Prevent+ Foam Sanitizer (NPN 80102490) |
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Prevent+ Rubbing Alcohol; Rubbing Alcohol 70%; (NPN 80103917) |
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First Aid Antiseptic: Prevent+ Hydrogen Peroxide 3% USP; Hydrogen Peroxide 3% USP; (NPN 80107321) |
Health Canada has suspended the company’s Medical Device Establishment Licence, COVID-SL (natural health product site licence) and natural health product licences to ensure the establishment no longer manufactures or sells any health products based on potential health and safety risks to Canadians.
Health Canada says it will continue to monitor the situation and will take appropriate and timely action should new information become available. Health Canada will also communicate any new safety information to healthcare professionals and consumers.
Consumers are advised to:
- If you have purchased any health product(s) listed above, stop using them and discard them appropriately:
- Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste; or
- Return the product to your local pharmacy for proper disposal.
- If you have undergone procedures where the gel was applied to or introduced into the body, and you are feeling unwell (e.g., having a fever and/or feeling tired) following an ultrasound, seek immediate medical attention.
- Since Eco-Med Pharmaceuticals Inc. has ceased operations, you should report any side effects from these health products directly to Health Canada.
Healthcare professionals are advised to:
- Immediately stop using and discard all products listed (see above).
- Consider assessing patients who have recently had an ultrasound or other treatment using the affected gels or lotions, and have an unusual or persistent infection, or are feeling unwell, for potential infection with Burkholderia stabilis or other bacteria.
- Since Eco-Med Pharmaceuticals Inc. has ceased operations, you should report any side effects from these health products directly to Health Canada.
