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Natural health product (Flora Essentials) recalled due to potential contamination with the antibiotic chloramphenicol
- Starting date:
- October 10, 2013
- Posting date:
- October 10, 2013
- Type of communication:
- Natural health products
- Source of recall:
- Health Canada
- General Public
- Identification number:
- Products affected
- What you should do
- Who is affected
- Report health or safety concerns
- Media enquiries
- Public enquiries
- What Health Canada is doing
Adeeva Nutritionals Inc., in consultation with Health Canada, is voluntarily recalling its natural health product “Flora Essentials” – a digestive aid – due to a possible contamination with chloramphenicol, an antibiotic that may pose serious health risks to consumers. Chloramphenicol is associated with a rare risk of aplastic anemia, a serious blood disorder that can be fatal. This reaction is unpredictable and not related to a specific dose of chloramphenicol.
Chloramphenicol is a prescription drug and should only be used under medical supervision in adults and children after careful consideration of the risks associated with it use. Other side effects that can be associated with chloramphenicol include allergic reactions in people who have sensitivity to the medication, and effects on the bone marrow leading to decreased blood cells. In addition, it should not be used in pregnant or lactating women.
- Flora Essentials (NPN 80039819) Lot #10342
What you should do
- Consult your healthcare practitioner immediately if you have used this product.
- Report any adverse events using this product to Health Canada.
- Contact Adeeva Nutritionals Inc. at 1-888-251-1010 (ext. 1014) to return the product.
Who is affected
Canadians who have used this product. The company and Health Canada have not received any reports of adverse reactions associated with this product.
Report health or safety concerns
To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:
- Fax: 1-866-678-6789
- Internet: www.healthcanada.gc.ca/medeffect
Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
What Health Canada is doing
Health Canada is monitoring the recall of “Flora Essential” by the company.
According to the company, testing of one of the raw materials used to produce this product identified the presence of chloramphenicol.
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- Date modified: