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SAFETY BULLETINS

January 23, 2017

Drug Alert: Fluoroquinolone antibiotics may in rare cases cause severe side effects

Health Canada’s recent safety review of oral and injectable fluoroquinolones, a class of antibiotics, found that in rare cases some known side effects may be persistent or disabling. This includes muscular issues such as tendonitis and Achilles tendon rupture, nerve damage such as peripheral neuropathy, and central nervous system issues such as anxiety, dizziness and confusion.

As a result of its safety review, Health Canada is working with manufacturers to include information concerning this rare but serious risk in the product labelling of these drugs.

Fluoroquinolone antibiotics are used to treat several types of infections, including respiratory and urinary tract infections. Reactions can occur hours to weeks after taking a fluoroquinolone.

January 24, 2017

Recall: Activated Charcoal Products

Health Canada is advising Canadians that four lots of activated charcoal products are being recalled by the company Omega Laboratories Ltd. because they may pose health risks. Children and people with weakened immune systems are at particular risk. The company has confirmed that two lots have microbial contamination (Charac-25 lot 8HL and Charac-Tol 50 lot 9HL) and is recalling the other two lots as a precaution (Charac-50 lot 7HL and Charac-Tol 25 lot 10HL). These products are used in emergency situations to treat poisoning by most drugs and chemicals. They are used mainly in healthcare settings such as hospitals, but are also sold in stores such as pharmacies.

January 24, 2016


Unauthorized Supplement: Poppers and sexual enhancement products


Health Canada is advising Canadians that it has seized unauthorized health products being sold at 24 Hour Adult Mart on Yonge St., Toronto, ON (units 540, 538 and 536). Three of the seized products are “poppers” (Rush, Ram and The Original Jungle Juice Platinum) labelled to contain alkyl nitrites. These can be dangerous if inhaled or ingested. The other seized products are promoted for sexual enhancement and labelled to contain drugs that may pose serious health risks (DHEA, pregnenolone, and yohimbe/yohimbine). What you should do: Stop using these products. Consult with your health care professional if you have used any of these products and have health concerns.

December 14, 2016


Unauthorized Drug Alert: Control-Max


Sale of an unauthorized prescription drug (yohimbine). Health Canada recalls this drug from distributors and retailers. For questions, contact Health Canada.

December 19, 2016


Medical Device Recall: Merge Eye Station


This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an eye station user. In the current workflow, a user can select to delete a record(s). When that selection is made, a confirmation box is presented asking the user if they want to delete the record(s). The user can then either left click on "ok" or press the "enter" key to confirm the action. Currently, this confirmation defaults to "ok" or "yes". In this workflow, a user could inadvertently hit the "enter" key, which would delete the images or procedures. Once these images or procedures are deleted, they are lost permanently with no recovery.

December 22, 2016


Unauthorized Supplement: Lithium Plus, Serotonin Support, and Brain Support


Health Canada is advising Canadians that three unauthorized products, “Lithium Plus, Serotonin Support, and Brain Support,” may pose serious health risks because they may contain the prescription drug Lithium Orotate. The products were offered for sale online and marketed to contain Lithium Orotate by the company Cutting Edge Naturals at cuttingedgenaturals.com and cuttingedgenutraceuticals.com

December 1, 2016

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

The products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Bee Sexy Slimming capsules, Biolo World Slimming capsules, ele Slim Shot, LifeSparks 100% Natural PAIN RELIEF SUPPLEMENT, LONGRED Oyster-x, Stiff Bull Herbal Coffee, Wolfish Shark Viagra tablets.

December 1, 2016

A recent Health Canada safety review found that patients infected with both hepatitis B and hepatitis C viruses who are being treated for hepatitis C with direct-acting antivirals may experience a reactivation of their hepatitis B. Hepatitis B reactivation is the return of an active hepatitis B infection, which can lead to serious complications such as liver failure.

As a result, Health Canada is working with manufacturers to strengthen the prescribing information for these drugs with a new warning about this risk.Direct-acting antivirals are prescription medicines used to treat and, in most cases, cure chronic hepatitis C virus infections in adults. Without treatment, chronic hepatitis C virus infections can lead to serious liver problems, including cirrhosis (liver scarring), liver cancer and death.

When Health Canada completed its safety review in October 2016 there were no Canadian cases of hepatitis B reactivation. However, 13 international cases were identified. In some cases, the symptoms reported were consistent with moderate to severe hepatitis B reactivation, with one case resulting in liver failure requiring a liver transplant.

November 12, 2016

Health Canada is advising Canadians that the company Teleflex Medical is recalling certain lots of its “MAD Nasal™ Intranasal Mucosal Atomization Device” because they may not deliver a fully atomized (fine) spray of medication. This means patients may not receive the full dose, which could reduce the medication’s effectiveness. The devices are used primarily by medically trained personnel but can also be used by first responders and the general public, such as parents and other caregivers.

The “MAD Nasal” device can deliver a range of medications in emergency and non-emergency situations, usually in cases where an alternative route of drug administration (such as intravenous injection) isn’t ideal. In certain emergency situations, failure to deliver the full dose could lead to serious injury or death.

Sep 22, 2016


Erfa Canada 2012 Inc. and Health Canada have received reports of defective 250 mg Zarontin softgel capsules (DIN 00022799), a prescription epilepsy drug, including reports of patients experiencing a higher frequency of seizures after taking capsules that appeared cloudy, broken, leaking, sticky or clumping together. Zarontin is available as capsules or as a syrup. The syrup is not affected by this issue.

Zarontin is used to control absence - or petit mal - seizures. Such seizures last a few seconds and are noticeable by a blank or absent state. They are more common in children than adults.

The softgel capsules may be particularly susceptible to deterioration from temperature or humidity changes. Exposure to high humidity levels during, for example, storage, transportation or handling, can cause the capsules to swell or become sticky, and break or leak. Pulling apart capsules that have become stuck together can increase the chance of tears and leaks.

Defective capsules - such as those that are cracked or leaking - can lead to a loss of medicinal ingredient, reducing the effectiveness of the medication. This could potentially lead to a reappearance or an increase in the number of absence seizures among patients.

Given that not all capsules are defective, and to avoid a shortage of this medically necessary drug, Zarontin capsules are not being recalled at this time. Health Canada will continue to work with the company, Erfa Canada 2012 Inc., on this issue and will advise Canadians of new safety information as required. A communication is being distributed to advise pharmacists on this issue.

Sep 26, 2016


Further to a recent advisory, Health Canada is informing Canadians that Healthy Body Services Inc. is expanding its voluntary recall of Allmax-brand “Rapidcuts Shredded” capsules (NPN 80041658). All lots are now being recalled as a precaution after certain lots were found to contain an undeclared prescription drug (yohimbine hydrochloride). Taking a prescription drug unknowingly and without the supervision of a healthcare professional can pose serious health risks. The product is promoted as a work-out stimulant and fat-burner, and is sold at various retail outlets across Canada.

October 25, 2016

An increased risk of hemolysis or low hemoglobin has been observed when patients already being treated with SOLIRIS (eculizumab) were vaccinated against serogroup B meningococcal infection with Bexsero. To minimize the risk of hemolysis when patients who are being treated with SOLIRIS are vaccinated, it is recommended that these patients be vaccinated only after their disease has been controlled and within one week following SOLIRIS infusion, when the SOLIRIS concentration in the blood is considered to be relatively high.
It is recommended that : Unless the risks of delaying SOLIRIS therapy outweigh the risks of developing a meningococcal infection, all patients must be vaccinated with a meningococcal vaccine (against serotypes A, C, Y, W135, and B) prior to, or at the time of, initiating SOLIRIS. Patients who have initiated treatment with SOLIRIS less than 2 weeks after receiving a meningococcal vaccine be treated with appropriate prophylactic antibiotics for a period of 2 weeks post vaccination.

October 21, 2016

Health Canada is informing Canadians that the product Nature’s Power Solutions Acidophilus Blend contains undeclared milk allergens, which may pose serious health risks to people who are allergic or hypersensitive to milk. This unauthorized natural health product is marketed to help the colon and digestive system. It was sold at Joy in Health & Nutrition Inc., 4024-50 Street, Red Deer, Alberta.

Products affected: Nature’s Power Solutions Acidophilus Blend

October 20, 2016

Health Canada is following up with Canadians concerning the recent warning issued by the U.S. Food and Drug Administration (FDA) regarding possible safety issues involving homeopathic teething products in the United States.

At this time, there is no indication of a similar safety concern in Canada. We continue to follow up with Canadian manufacturers and the FDA, and to assess all available information. Should the Department determine that there is a safety concern involving products sold in Canada, we will take action and inform Canadians as appropriate.

There are several homeopathic teething products authorized in Canada, manufactured by different companies and available in multiple formats including gels, tablets and liquids (drops). Health Canada has received eleven Canadian adverse reaction reports involving a variety of these products since their sale: three that were serious but were confirmed, following an assessment, to be unrelated to the product; seven that were not serious; and one that was an allergic reaction that was determined to be possibly linked to the product. No deaths associated with homeopathic teething products have been reported in Canada.

Sep 30 2016


Health Canada seized five unauthorized products promoted as workout or weight loss supplements from Keebo Sports Supplements at 1504 St. Mary’s Road, Winnipeg, Manitoba (see table below). The products are labelled to contain various prescription and other drug substances that may pose serious risks to the health of Canadians. Products are: Yohimbine, Diesel Fuel Stim, Amp-Stim, HydroxyElite, Andro Quad.