Jan 3, 2014: Royal Jelly recalled due to contamination with the antibiotic chloramphenicol

The company Alive Health Centre, in consultation with Health Canada, is voluntarily recalling two lots of its natural health product Alive Vitamins - Royal Jelly 1200 mg due to 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 by pregnant or lactating women.

Products affected are:
Alive Vitamins - Royal Jelly 1200 mg (NPN 80034337) Lots: 21211147 and 21203128

Jan 23, 2014: Various Kinnikinnick Foods Brand products recalled due to undeclared milk

Kinnikinnick Foods is recalling the Kinnikinnick Foods brand products listed below from the marketplace because they contain milk which is not declared on the label. People with an allergy to milk should not consume the recalled products described below. The food recall warning issued on January 10, 2014 has been updated to include additional codes. This additional information was identified during the Canadian Food Inspection Agency's (CFIA) food safety investigation. The CFIA is verifying that industry is removing recalled products from the marketplace.

The following Kinnikinnick Foods brand products have been sold nationally.

Original Homestyle Waffles
Cinnamon & Brown Sugar Homestyle Waffles
Kinni-Kwik Bread & Bun Mix
Pancake & Waffle Mix
Panko Style Bread Crumbs

 

Dec 16, 2013: Lead found in Rublev Colour Paints and Varnish.

Health Canada has put out a recall on Rublev Colours Paints and Italian Varnish, commonly used in adult arts and crafts, as their random evaluation program found these products contain lead, a known neurotoxin. The manufacturer failed to label these products as such which may put many at risk of unexpected lead exposure, especially if ingested. These products are manufactured by Natural Pigments in the US however are distributed by ARTiculations in Toronto, Ontario. Approximately 94 recalled units have been sold during the period of November 2012 to November 2013. The Rublev Colours Paints were sold in 50 mL and 130 mL tubes, and the Rublev Colours Italian Varnish was sold in a 42 mL tube. Users are encouraged to should stop using the product and contact ARTiculations.

Products affected include:
Rublev Artists’ Oil paints
&nbsp&nbsp&nbsp&nbsp&nbsp- Lead white 1
&nbsp&nbsp&nbsp&nbsp&nbsp- Lead white 2
&nbsp&nbsp&nbsp&nbsp&nbsp- Venetian Medium
&nbsp&nbsp&nbsp&nbsp&nbsp- Flemish White
&nbsp&nbsp&nbsp&nbsp&nbsp- Crystal White
&nbsp&nbsp&nbsp&nbsp&nbsp- Lead Tin Yellow
&nbsp&nbsp&nbsp&nbsp&nbsp- Naples Yellow (Lead Antimonate)
&nbsp&nbsp&nbsp&nbsp&nbsp- Naples Yellow Paris
&nbsp&nbsp&nbsp&nbsp&nbsp- Chrome Yellow Light
&nbsp&nbsp&nbsp&nbsp&nbsp- Chrome Yellow Medium
&nbsp&nbsp&nbsp&nbsp&nbsp- Minium (Red Light)
Rublev Colours Italian Varnish

Dec 18, 2013: Food Alert: Undeclared Gluten found in Aurora Brand Corn Gnocchi and Rice Gnocchi

The Canadian Food Inspection Agency found undeclared gluten in Aurora Brand Corn Gnocchi and Rice Gnocchi. The manufacturer, Aurora Importing & Distributing is recalling its Aurora Brand Corn Gnocchi (500g, all lots, with UPC code 0 61659 01811 2) as well as Aurora Brand Rice Gnocchi (500g, all lots, with UPC code 0 61659 01792 4) because they may contain gluten.

This recall was triggered by a consumer complaint. There has been one reported reaction associated with the consumption of these products. The Canadian Food Inspection Agency (CFIA) is conducting a food safety investigation, which may lead to the recall of other products. If other high-risk products are recalled the CFIA will notify the public through updated Food Recall Warnings. Those with celiac disease or gluten intolerance should avoid this product.

November 22 2013: Certain Aguirre Honey Farms brand Goldenrod Honey may contain lead

The Canadian Food Inspection Agency has issued a recall of honey sold in Ontario due to concerns of possible lead contamination. The affected products are Aguirre Honey Farms 500g and 1kg packages of Goldenrod Honey. The source of the contamination has not been disclosed. Lead is a known neurotoxin and even small amounts of lead exposure can affect mental and physical development in young children who are particularly vulnerable, according to the Mayo Clinic. Signs and symptoms of lead poisoning in children include: The signs and symptoms of lead poisoning in children may include: irritability, loss of appetite, weight loss, sluggishness and fatigue, abdominal pain, vomiting, constipation, and learning difficulties.

November 15 2013:Unauthorized weight loss products OxyElite Pro linked to multiple reports of serious liver injury in the U.S.

Health Canada is advising Canadians of a U.S. Food and Drug Administration (FDA) warning not to use dietary supplements labelled as “OxyElite Pro” following several U.S. reports of serious liver injury. Certain OxyElite Pro dietary supplements are being recalled by the distributor, USPLabs LLC of Dallas, Texas (see list below).

OxyElite Pro products, which are promoted for rapid weight loss, are not authorized in Canada and have not been found on the Canadian market. However, they are widely available in the U.S. and over the Internet. Canadians may have purchased these products while shopping online or travelling. The affected products are: OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, and OxyElite Pro Super Thermo Powder.

To date, no adverse reactions have been reported to Health Canada involving OxyElite Pro, however, several dozen U.S. cases of liver damage have so far been potentially linked to OxyElite Pro. These include at least one case resulting in a liver transplant, and one death. Symptoms of liver injury can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.

The U.S. FDA and the Centre for Disease Control are continuing their investigation regarding OxyElite and the reports of hepatic adverse reactions.

What you should do

•&nbsp&nbsp&nbsp&nbspDo not use OxyElite Pro products and consult with a healthcare professional if you experience symptoms of liver injury or other health concerns related to their use.

•&nbsp&nbsp&nbsp&nbspContact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if you find OxyElite Pro products in the Canadian marketplace.

•&nbsp&nbsp&nbsp&nbspUse only health products that have been evaluated by Health Canada for safety, effectiveness, and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.

To report a side effect to a health product to Health Canada:

•&nbsp&nbsp&nbsp&nbspCall toll-free at 1-866-234-2345

•&nbsp&nbsp&nbsp&nbspVisit MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

November 22 2013: In vitro fertilization product (Endometrin) recalled due to possible problems with effectiveness

Ferring Pharmaceuticals, in consultation with Health Canada, is voluntarily recalling two lots of Endometrin (100mg progesterone tablet), a prescription medication used during in vitro fertilization. The lots (0804.209A-1 and 0804.219A-1) were released in July and September of 2013, according to the company.

The voluntary recall is a precautionary measure due to the potential damage of tablets from a packaging equipment malfunction that has caused brown discolouration of some tablets and/or blister packs. As a result, the company has informed Health Canada that the discoloured tablets could potentially be altered, which could affect the therapeutic effectiveness of the product and lead to early pregnancy loss. According to the company, the problem has occurred with different lots in other countries but has not been seen with the lots in Canada to date.

Health Canada has not received any reports of adverse events as of November 15, 2013 associated with Endometrin. Ferring Pharmaceutical has also indicated that it has not received any reports of adverse events for this product. Health Canada is monitoring the recall and will update Canadians should new information be identified.

Patients are advised to contact their healthcare professional if they have any concerns or questions about Endometrin. Patients should not stop taking their medication without consulting with their healthcare professional.

Ferring Pharmaceuticals will be issuing a Dear HealthCare Professional Letter officially notifying implicated healthcare professionals of the voluntary recall of two lots of Endometrin. This is a precautionary measure as there have been no reports of discoloured tablets or packages in Canada. The discolouration results from a packaging equipment malfunction which may damage the tablets and impact treatment effectiveness.

October 18 2013: A number of natural health products potentially contaminated with chloramphenicol may pose serious health risks to consumers

October 18 2013: Health Canada is informing Canadians that several natural health products are being voluntarily recalled by a number of Canadian companies due to a possible contamination with chloramphenicol, an antibiotic that may pose serious health risks to consumers.

Specialty Enzymes & Biotechnologies has provided contaminated raw materials to a number of companies producing natural health products for the Canadian market. As a result, natural health products from these companies are at risk of contamination with chloramphenicol.

The only products Health Canada is currently aware of potentially being contaminated are products used as digestive aids. Health Canada is working with Specialty Enzymes & Biotechnologies and its Canadians customers to confirm affected products and will continue to provide updates to Canadians as warranted. 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 its 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 by pregnant or lactating women.

Products that have been identified as affected are:

Valeant Canada	Digestive Enzymes 500mg Capsules	NPN#: 80033138
Natural Factors	Multi Enzyme capsules	NPN#: 02245142
Natural Factors	Complete Megazymes tablets	NPN#: 00506508
WN Pharmaceuticals®	Complete digestive Enzymes caps	NPN#: 02248630
WN Pharmaceuticals®	Complete digestive Enzymes caps - blister pack	NPN#: 02248630
WN Pharmaceuticals®	Digestive Enzymes tablets	NPN#: 02240677
Renew Life Canada	GasStop	NPN#: 80036717
Renew Life Canada	DigestMORE HCl	NPN#: 80037271
Renew Life Canada	Advanced Naturals DigestMAX	NPN#: 80037271
Renew Life Canada	DigestMORE	NPN#: 80005847
Renew Life Canada	Advanced Naturals DigestMAX	NPN#: 80005847
Renew Life Canada	CandiZYME	NPN#: 80036437
Renew Life Canada	DigestMORE ULTRA	NPN#: 80037290
Future Formulations	NaturPham M2+	NPN#: 02240497
Future Formulations	NaturPham M3+	NPN#: 02240501
Future Formulations	NaturPham M4+	NPN#: 02240561
Future Formulations	NaturPham M5+	NPN#: 02240572
Future Formulations	NaturPham M6	NPN#: 02239966
Future Formulations	NaturPham M7+ Capsules	NPN#: 02240571
Future Formulations	Digestion Formula Forte	NPN#: 02240559
Future Formulations	Digestion Formula C	NPN#: 02240495
Future Formulations	Digestion Formula F	NPN#: 02240496
Future Formulations	Tumi-Ease	NPN#: 02239965
Accurex Health Care	First - PrimeZyme Plus Betaine	NPN#: 80039724
Gourmet Nutrition	Kamizym-U	NPN#: 80036136
Gourmet Nutrition	Kamizym+	NPN#: 80033802
Metagenics Canada	Spectrazyme	NPN#: 80044751
Adeeva Nutritionals	Flora Essentials	NPN#: 80039819

Oct 11 2013: Contamination problem highlights need to use quality products

Oct 11 2013: A research team based out of the University of Guelph recently published their analysis of 44 herbal products available in stores across Canada, showing a high rate of contamination. The researchers used a DNA matching technique to identify species of herbs present in these products, and compare them to those listed on the product labels.

Herbal products available to consumers in the marketplace may be contaminated or substituted with alternative plant species and fillers that are not listed on the labels. According to the World Health Organization, the adulteration of herbal products is a threat to consumer safety. This study aimed to investigate herbal product integrity and authenticity with the goal of protecting consumers from health risks associated with product substitution and contamination.

A DNA test was used to test the authenticity of 1) 44 herbal products representing 12 companies and 30 different species of herbs, and 2) 50 “raw” leaf samples collected from 42 herbal species. Researchers found that most of the products tested (59%) contained DNA from plant species not listed on the labels. Product substitution occurred in 30 of 44 of the products tested, and only 2 of 12 companies had products without any substitution, contamination or fillers. Some of the contaminants identified may pose serious health risks to consumers.

Researchers suggested that companied incorporate a DNA herbal barcode library for testing bulk materials in order to authenticate materials used. The study also underscores the need for consumers to seek out only high quality natural health products.

Sept 27 2013:FDA warns of increased risk of death with IV antibiotic and approves new Boxed Warning

Sept 27 2013: The U.S. Food and Drug Administration (FDA) is warning that an additional analysis shows an increased risk of death with use of the intravenous (IV) antibiotic, Tygacil (tigecycline). A new Boxed Warning about this risk is to be added to the Tygacil drug label, and the Warnings and Precautions and the Adverse Reactions sections of the drug information will be updated. A Boxed Warning is the strongest warning given to a drug. These changes are based on an analysis that was conducted following an initial Drug Safety Communication about this concern in September 2010

Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable. Tygacil is FDA-approved to treat complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. Tygacil is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia. Patients and their caregivers should talk with their health care professionals if they have any questions or concerns about Tygacil.

Data from 10 clinical trials conducted only for FDA-approved uses of this drug showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% vs. 1.8%, respectively. The adjusted risk difference for death was 0.6%. In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.

The latest Tygacil label can be accessed on the FDA webpage: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf