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SAFETY BULLETINS

September 2, 2014

Health Canada is recalling specific batches of the drug Serophene. Report of a new impurity (called bromo analogue of Clomiphene Citrate) at above ICH specification (NMT 0.10%) level in API batches were used in the manufacturing of Serophene 50mg tablets. Please contact Health Canada for further information if you are impacted.

August 18, 2014

Health Canada is advising healthcare professionals and Canadians that it has implemented labelling changes for the class of drugs known as controlled-release opioid pain medicines, to enhance their safe and appropriate use. The changes provide standardized wording that more clearly outlines the risks and safety concerns associated with controlled-release opioids. The updated label also encourages more appropriate patient selection and monitoring. While an effective pain treatment, opioid medications carry risks and can have serious negative health impacts, even at recommended doses. Their use can also lead to accidental overdose and death. The label changes seek to reduce these risks, which include addiction, misuse and abuse, while preserving access for those who need them most.

There are currently 38 brand name and generic controlled-release opioid medicines in Canada and include, among others, controlled-release versions of morphine, oxycodone, and fentanyl.“Controlled release” medications are designed to be long acting, meaning they produce gradual, steady absorption of the drug in the body over an extended period of time, which allows patients to take them less often. The changes apply now to all classes of controlled and extended release non-generic opioids. Similar label changes will soon be implemented for generic opioids.

The approved use for all opioids in this class has been modified to remove use for “moderate” pain. The new label clarifies that these drugs are indicated for the management of pain severe enough to require daily, continuous, long-term opioid treatment that is opioid-responsive and for which alternative treatment options are not adequate. The changes preserve the ability for prescribers to choose appropriate treatment for their patients, but provide clearer guidance on the recommended patient population. In addition, existing warnings and safety information have been made clearer, including health risks to children from accidental exposure and to newborns exposed during pregnancy. Warnings with respect to opioid addiction potential have also been strengthened and made clearer. As well, the changes standardize label information, and ensure information targeted to patients is easier to read and understand.

August 11, 2014

These 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: Sanovera Starter Capsules, Yanhee Slim, Infinity, Asset Bee Pollen, Asset Bold, Slim Trim U, Natural Body Solution, and 3X Slimming Power capsule. Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of July 7, 2014, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada. Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products listed above in the Canadian marketplace. Canadians who have these products are advised not to use them, and should consult with a healthcare professional if they have concerns about their health related to the use of these products.

August 6, 2014

GlaxoSmithKline Inc., in consultation with Health Canada, has informed health care professionals of important new updates to safety information regarding infusion reactions related to ARZERRA™. ARZERRA™ is a medication that is administered into the veins to treat chronic lymphocytic leukemia (CLL), a type of blood cancer. A severe infusion reaction resulting in death was reported in a patient with CLL who was given ARZERRATM. Signs and symptoms of an infusion reaction may include the following: swelling of face or mouth, fever,chills, difficulty breathing, tightness of the chest and/or throat, lightheadedness, nausea, diarrhea, and rash. These symptoms can occur during or shortly after the infusion of ARZERRATM. If you experience these or any other symptoms, please notify your health care provider immediately.

The prescribing information for ARZERRATM is being revised to include new information regarding the potential for fatal infusion reactions. Patients are reminded that it is important to be closely monitored during and after the infusion by a health care professional, especially if you have a heart condition. Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious hypersensitivity or infusion reactions or other serious or unexpected side effects in patients receiving ARZERRA™ should be reported to GlaxoSmithKline or Health Canada.

August 1, 2014

The food recall warning issued on July 21, 2014 has been updated to include additional product code information. This additional information was identified during the Canadian Food Inspection Agency's (CFIA) food safety investigation. Industry is recalling Sweet 2 Eat brand fresh, whole peaches, plums, nectarines and pluots from the marketplace due to possible Listeria monocytogenes contamination. These products were recalled by Wawona Packing Company of California. Consumers should not consume the recalled products described below. Note that retail cartons may show the following brand names: Wawona, Sweet 2 Eat or Harvest Sweet. Stickers on individual fruit have the Sweet 2 Eat brand name.

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased. Consumers who are unsure whether they have the affected products are advised to check with their retailer or supplier. Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still make you sick. Symptoms can include vomiting, nausea, persistent fever, muscle aches, severe headache and neck stiffness. Pregnant women, the elderly and people with weakened immune systems are particularly at risk. Although infected pregnant women may experience only mild, flu-like symptoms, the infection can lead to premature delivery, infection of the newborn or even stillbirth. In severe cases of illness, people may die.

July 30, 2014

Merck Canada Inc., in consultation with Health Canada, would like to inform you of new Contraindications that have been added to the NUVARING® Product Monograph (PM). NUVARING® is a combined hormonal contraceptive (CHC) indicated for conception control. The following points summarize the important changes that have been made to the PM: NUVARING® should NOT be used by women who smoke (if over age 35), or who have severe or multiple risk factors for thrombosis, including: valvular heart disease with complications, hypertension, severe dyslipoproteinemia, abnormality in proteins that regulate coagulation, diabetes mellitus with vascular involvement, or major surgery with prolonged immobilization. NUVARING® should NOT be used by women who have experienced migraines with focal neurological symptoms, or pancreatitis associated with severe hypertriglyceridemia.

In addition to the above contraindications, changes have also been made under WARNINGS AND PRECAUTIONS section of the PM regarding the following possible adverse events: systemic lupus erythematosus, sydenham’s chorea, herpes gestationis, otosclerosis-related hearing loss, hepatocellular carcinoma, Crohn’s disease, colitis ulcerosa and angioedema. Merck Canada Inc., in working with Health Canada, has updated the NUVARING® PM regarding the above new contraindications and warnings which are also associated with other CHC products.

June 17, 2014 Multiple Foreign Product Alerts

Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality. As of May 15, 2014, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada. These 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.

The products are: Phen Tabz, Asset Extreme, Asset Extreme Plus, Meizitang Citrus, Slimming Diet Berry Plus, Citrus Fit Gold, Hot Detox, Thinogenics, Tonic Life BP, Slimfast Capsules, Dr. Ming's Chinese Capsule, Magic Slim, Apple’s Quick Impact Weight Loss. Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products listed above in the Canadian marketplace. Canadians who have these products are advised not to use them, and should consult with a healthcare professional if they have concerns about their health related to the use of these products.

June 7, 2014 Food Alert: Various products containing sprouted chia seed powder recalled due to Salmonella

The food recall warning has been updated to include additional product information. This additional information was identified during the Canadian Food Inspection Agency's (CFIA) food safety investigation. This recall was triggered by findings by the CFIA during its investigation into a foodborne illness outbreak. The 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. The CFIA is verifying that industry is removing recalled products from the marketplace.

BioEssential Botanicals is voluntarily recalling sprouted chia powder sold in bulk due to possible Salmonella contamination. The bulk product has been used to manufacture various products under several brand names. Consumers should not consume the recalled products described here: http://healthycanadians.gc.ca/recall-alert-rappel-avis/inspection/2014/…. Please note that the affected products listed in the table may have been sold without a code marked on the package. These products without a code would also be included in the recall.

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased. Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.

May 29, 2014 Natural Health Product Alert: Heartland Natural Wild Yam Moisturizing Cream Recalled by Health Canada

Health Canada is recalling Heartland Natural Wild Yam Moisturizing Cream due to lab results that have confirmed undeclared Progesterone in the product. The addition of this hormone could cause adverse health effects or drug interactions for the public. All lots are affected. Please contact Health Canada if you have obtained or used this product. When a product is recalled, or an advisory or alert is issued, it means Health Canada surveillance tools are working. Recalls and safety alerts are sent when Health Canada has important information to share, meaning you can feel more secure when choosing and using products.

May 23rd, 2014 Drug Alert: Hypertension drug PMS-Losartan-HCTZ recalled due to labelling error

PMS-Losartan-HCTZ 100/25mg is a combination product of both losartan (100 mg) and hydrochlorothiazide (HCTZ, 25mg) used for the treatment of hypertension (high blood pressure). One lot is being recalled due to a labelling error on the inner package or blister. Taking two 100/25mg tablets instead of one to obtain the correct amount of HCTZ would result in a double dose of both components (losartan and HCTZ) of this product and potential serious adverse effects. The possible risks of a double dose include hypotension (low blood pressure), fast heart rate, and depletion of electrolytes (or salts) in the body and dehydration.

Pharmascience Inc., in consultation with Health Canada, is recalling one lot of PMS-Losartan-HCTZ due to a labelling error on the blister pack. The printed boxes of the product show the proper dosage “Losartan-HCTZ100/25mg,” while some blisters or inner packages incorrectly say “Losartan-HCTZ 100/12.5mg.” The product is packaged with 100/25mg tablets. Taking more of the drug than prescribed could have serious health effects. The product affected is PMS-Losartan-HCTZ (Lot number: 0300804). If you are taking this product, check the packaging for the lot number. If this is the affected lot, return the product to your pharmacist and obtain a replacement.

May 9, 2014 Drug Alert: Health Canada suspends license of Biolyse Pharma, but supply of paclitaxel will not be disrupted for Canadians

Health Canada confirmed it has suspended the establishment licence of Biolyse Pharma Corporation's facility in St. Catharines, Ont., because of significant concerns with the manufacturing process discovered during a recent inspection. Injectable paclitaxel (6mg/ml), used in the treatment of certain lung and breast cancers, is currently the only drug produced at that facility. The suspension of the establishment license means Biolyse is not permitted to sell paclitaxel from that facility to the Canadian market until the serious manufacturing concerns are fully addressed and the suspension on their establishment licence is lifted. To receive and maintain an establishment licence in Canada, a company must comply with Good Manufacturing Practices (GMP), which help to ensure that the drugs sold in Canada are safe, effective and of high quality. These guidelines are applied to all companies and are widely known.

Health Canada has confirmed that supplies of paclitaxel are available from another manufacturer that is licenced to produce it in Canada. The Department is also in regular contact with the provinces and territories regarding the supply situation. There has been no supply disruption caused by the licence suspension. In the short term, Health Canada is allowing the Biolyse product currently on the market to continue to be used for treatment. However, Health Canada cannot be assured that future supplies of paclitaxel from Biolyse would be safe and effective for use by patients until the serious manufacturing violations are resolved. Patients currently being treated with paclitaxel from Biolyse should speak to their healthcare professional if they have concerns with their treatment. Health Canada officials continue to work with the staff at Biolyse Pharma to resolve the issues identified during the inspection as quickly as possible.

May 9, 2014 Food Alert: Selection brand Rosemary Leaves recalled due to Salmonella

Nador Inc. is recalling Selection brand Rosemary Leaves from the marketplace due to possible Salmonella contamination. Consumers should not consume the recalled product described below.

Check to see if you have recalled product in your home. Recalled products should be thrown out or returned to the store where they were purchased. Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.

May 7, 2014
Drug Alert: Association of TEMODAL® (temozolomide) with the risk of liver problems.


Merck Canada Inc., in consultation with Health Canada, would like to inform you of new important safety information about TEMODAL® (temozolomide) and risk of liver problems. TEMODAL® is an antitumor agent used in combination with radiotherapy in the treatment and maintenance therapy of some brain cancers. TEMODAL® may cause liver problems which may, in some cases, result in death. Liver problems may occur several weeks after starting treatment with TEMODAL® or after treatment has been stopped. If you are using TEMODAL®, your doctor will be monitoring you for signs of liver problems with blood tests as appropriate for your condition. It is important to tell your doctor if you already have liver problems.

Contact your doctor if your skin or the whites of your eyes turn yellow, you feel tired or have flu-like symptoms, your urine is dark or brown, your stools are discoloured and/or pale, you experience itching, you have nausea or vomiting, you have pain on the right side of your stomach just below the ribs, or you do not have an appetite. These may be signs of liver problems. Merck Canada Inc. has sent a letter to health care professionals informing them of this important safety information.


April 17, 2014 Food Alerts: Noah's Natural Foods is recalling organic black peppercorns from the marketplace due to possible Salmonella contamination.


Noah's Natural Foods is recalling organic black peppercorns from the marketplace due to possible Salmonella contamination. Consumers should not consume the recalled product. There is no brand name associated with the product (it is sold in bulk as Organic Black Peppercorn). Locations include Noah's Natural Foods @ 322 Bloor St. West, Toronto and Noah's Natural Foods @ 2395 Yonge St., Toronto.

Check to see if you have recalled product in your home. Recalled products should be thrown out or returned to the store where they were purchased. Food contaminated with Salmonella may not look or smell spoiled but can still make you sick. Young children, pregnant women, the elderly and people with weakened immune systems may contract serious and sometimes deadly infections. Healthy people may experience short-term symptoms such as fever, headache, vomiting, nausea, abdominal cramps and diarrhea. Long-term complications may include severe arthritis.


April 17, 2014 Product Recall: Kiss My Face, LLC Recalls Foaming Soaps due to possible bacterial contamination.


Kiss My Face, LLC is recalling their foaming soaps that were sold from November 5, 2012 until March 13, 2014. The recalled products are contaminated with the bacteria Pseudomonas aeruginosa and Pseudomonas fluorescens. Pseudomonas species can enter the body through cuts and lesions and may cause local infections in people with weakened immune systems. Neither the company nor Health Canada has received any reports of consumer incidents or injuries related to the use of these products. Approximately 19,000 units of the affected products were sold in Canada.

Consumers should immediately stop using the recalled products even if it does not look or smell spoiled. Consumers who purchased any of the lots being recalled are advised to return the product container to the original point of purchase for reimbursement. Alternatively consumers can contact Kiss My Face directly at 1-800-262-5477 (Monday to Friday, 9:00 a.m. to 5:00 p.m. EST, available in English only), or via email at customerservice@kissmyface.com.