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SAFETY BULLETINS

May 25, 2017

Unauthorized Products: Seizure from adult stores in Scarborough

Health Canada is advising Canadians that multiple unauthorized health products seized from two retailers in Scarborough, ON, may pose serious risks to health. Products seized include “poppers” and products promoted for sexual enhancement.

May 30, 2017

Online Drugs Warning: Health Canada warns about L-tryptophan and lithium orotate

Health Canada is advising Canadians that multiple unauthorized products labelled to contain L tryptophan or lithium orotate were being sold on amazon.ca, and may pose serious health risks. L Tryptophan (at doses higher than 220 mg per day) and lithium orotate are prescription drugs in Canada and should be used only under the supervision of a health-care professional.

All drug products sold in Canada, including those sold over the Internet, must be approved for sale by Health Canada. Taking drugs that have not been authorized by Health Canada may pose serious health risks, as they have not been assessed for safety, effectiveness, or quality.

Prescription drugs should be obtained only from pharmacies that are licensed by the applicable province or territory in which they operate. Consumers who take a prescription drug without being examined and monitored by a health-care professional may not receive appropriate treatment. They may also put themselves at risk for harmful drug interactions and dangerous side effects.

February 10, 2017

Supplement Alert: Unauthorized supplements seized from Chateauguay

Health Canada is advising Canadians that it has seized unauthorized health products promoted as workout, weight loss and dietary supplements from Atomik Nutrition at 102-90 Boul. Saint-Jean-Baptiste, Châteauguay, QC (list available on Health Canada’s website). The products are labelled to contain various drugs, including prescription and controlled drugs, which may pose serious risks to the health of Canadians.

February 13, 2017

Health Advisory: Risk of skin burns with over the counter pain relievers with menthol

Health Canada is advising Canadians that a safety review has found a risk of serious skin burns with the use of certain over-the-counter (OTC) topical pain relievers containing menthol. These pain relievers are applied to the skin to produce mild irritation or inflammation intended to help relieve muscle and joint pain. They contain one or more active ingredients and come in various formulations, including creams, gels, liquids and patches.

While a minor rash or a burning sensation are a known side effect, more serious effects like skin burns, pain, blistering or other severe skin damage are not generally expected from the use of these products. Health Canada has received 21 reports of serious side effects involving OTC topical pain relievers containing menthol in various concentrations (containing 0.75% to 11% menthol), as a single ingredient or in combination with other ingredients (most commonly methyl salicylate). In many cases, the products were used as directed, with burns, severe swelling and blistering appearing within 24-48 hours of the first application.

February 21, 2017

Drug Recall: PMS-Propofol recalled

Health Canada is advising Canadians that a recall is occurring for PMS-Propofol because several batches were contaminated by foreign particles. For more information, please visit the Health Canada website.

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

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.

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.

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.