2005-86
August 8, 2005For immediate release
Advisory
OTTAWA -- Health Canada is reminding consumers not to use Miracle II Miracle Neutralizer or any health products exported or sold by Tedco, Inc. of Louisiana, due to the risk that they could contain harmful bacteria. Miracle II Miracle Neutralizer is a natural health product sold for uses such as heartburn, sunburn, pet and plant health, and vegetable cleaning. It comes in normal strength, double strength, and triple strength. Miracle II Miracle Neutralizer is also available in concentrated liquid form or powder for agricultural use. It can be taken orally or applied directly to the skin. These products are not authorized for sale in Canada.
A recall was requested by Health Canada in May 2005, but Health Canada remains concerned that some consumers are not aware of the recall and that the company and many of its distributors continue to sell the products through the mail. As a result, the products may still be in the hands of consumers. Health Canada is continuing to work with as many distributors as possible to remove these products to the extent possible from the consumer market.
This warning is a reminder of previous warnings issued on May 12 and 30, 2005, that warned Canadians not to use Miracle II Miracle Neutralizer.
Health Canada's analysis of a sample of this product found that the "Miracle II Miracle Neutralizer" was contaminated with the harmful bacteria, Escherichia coli (E. coli).
Health Canada asked Tedco, Inc. to provide evidence that their other health products are not contaminated with E. coli. The company has refused to cooperate at this time and did not provide Health Canada with any information. As a result, Health Canada cannot be sure that other products by Tedco, Inc. do not contain the harmful bacteria.
Using products that contain this harmful bacteria may result in serious adverse reactions or death. Adverse health reactions can include nausea, severe diarrhea, body rash and fever. Children may be more sensitive to these effects than adults.
The following is a list of the known Tedco, Inc. health products that Canadians are warned not to use:
Miracle II Neutralizer available in 22 oz. or 1 gallon liquid.
Miracle II Neutralizer 2X available in 22 oz. or 1 gallon liquid.
Miracle II Neutralizer 3X available in 22 oz. or 1 gallon liquid.
Miracle II Neutralizer available in 8 oz., 22 oz. or 1 gallon gel.
Miracle II 7X Neutralizer available in 8 oz., 22 oz. or 1 gallon gel.
Miracle II Neutralizer available in powder and makes 1 gallon.
Miracle II products are sometimes referred to as Miracle 2.
These products are mainly sold directly to consumers through the Internet or by individual distributors, but were also found in retail stores. Canada Border Services Agency has been notified to prevent further Tedco, Inc. products from being imported into Canada. If Canadians have taken or have been exposed to any products from Tedco, Inc. and have experienced any symptoms, or are concerned about their health, they are advised to consult their physician immediately.
To date, Health Canada has received no reports of adverse reactions associated with Tedco, Inc. products. To report a suspected adverse reaction, health professionals and consumers may contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by phone, toll free 1-866-234-2345, by fax 1-866-678-6789 or via email: cadrmp@hc-sc.gc.ca. Consumers can also visit Health Canada's website at: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_adverse_e.html
Consumers with this product are advised not to dispose of the contaminated product until they have received guidance from their municipal government regarding its safe disposal.
As a reminder, products that have been approved for sale in Canada must meet the health and safety requirements of the Food and Drugs Act and its associated regulations. The marketing authorization may be in the form of a Drug Identification Number (DIN) or a natural health product licence, as denoted by a Natural Product Number (NPN) or a Homeopathic Drug Number (DIN-HM).
Canadians are encouraged to contact Health Canada's Health Products and Food Branch Inspectorate if they have any questions about this advisory at this toll-free number: 1-800-267-9675.
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Media Inquiries:
Christopher Williams
Health Canada
((613) 946-4250
Public Inquiries:
(613) 957-2991
