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ZENHALE (mometasone furoate/formoterol fumarate dihydrate inhalation aerosol) - Recalled Lots Due to the Possibility of Device Malfunction After 24 Months Shelf-Life
- Starting date:
- February 27, 2015
- Posting date:
- February 27, 2015
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Important Safety Information
- Healthcare Professionals, General Public
- Identification number:
This is duplicated text of a letter from Merck Canada Inc. prepared in collaboration with Health Canada.
Patients affected and Health Professionals working in the following settings: Respirology, Internal Medicine, Family Practice, Pediatrics, Allergy, Pharmacy, Emergency Medicine.
- Merck Canada is initiating a recall of certain lots (see attached list) of ZENHALE® due to the possibility of device malfunction after 24 months shelf-life, resulting in the potential for a patient to receive a lower dose than expected.
- If a patient receives a lower dose of ZENHALE® than expected, they may experience increased asthma symptoms and worsening asthma control, including serious asthma exacerbation.
- Pharmacists and physicians should immediately stop distribution and quarantine all lots of these products with lot numbers shown on the attached list. Affected product should be returned as per the directions in the Recall Notice.
Merck Canada is initiating a recall of certain lots (see attached list) of ZENHALE® at the pharmacy/physician level due to the possibility of device malfunction of ZENHALE® after 24 months shelf-life, resulting in the potential for a patient to receive a lower dose than expected. The company’s investigation has determined that the occurrence of this defect is low.
Merck Canada expects new ZENHALE® product to be available in pharmacies by March 23, 2015. Merck Canada will reduce the shelf life of all ZENHALE® products from 36 months to 24 months. The new product will have a shelf-life of 24 months.
ZENHALE® (mometasone furoate/fomoterol fumarate dihydrate)
Refer to the list of lots at the end of this communication.
ZENHALE® (mometasone furoate/formoterol fumarate dihydrate inhalation aerosol), is indicated for the treatment of asthma, in patients 12 years of age and older with reversible obstructive airway disease.
Who is affected
Information for consumers
If a patient is using an inhaler from the specific lots of ZENHALE® listed in this communication, including samples, and notices that the device is not functioning properly and/or experiences an increase in asthma symptoms, they should contact their pharmacist as soon as possible and obtain a replacement or a prescription for an alternative medication from their physician, if ZENHALE® is not available.
Patients who have any questions should contact their health care professional.
Information for health care professionals
ZENHALE® metered dose inhalers from the affected lots should be returned as outlined in the Recall Notice issued by Merck Canada Inc. on February 26, 2015. This recall also includes samples in physicians’ offices.
Merck Canada expects new ZENHALE® product to be available in pharmacies by March 23, 2015. Meanwhile, health care professionals are asked to ensure that their patients are safely transitioned to alternative products, if supply of ZENHALE® is not available.
Action taken by Health Canada
Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Health Canada is also monitoring the recall and the implementation of necessary corrective and preventive actions.
Report health or safety concerns
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving ZENHALE® should be reported to Merck Canada Inc. or Health Canada.
Merck Canada Inc., Pharmacovigilance
16750 Trans-Canada Hwy.
Kirkland, Québec H9H 4M7
Merck Canada Inc. Medical Information Centre
Tel: 514-428-8600 or 1-800-567-2594
Fax: 514-428-8675 or 1-877-428-8675
To correct your mailing address or fax number, contact Merck Canada Inc.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax
For other health product inquiries related to this communication, contact Health Canada at:
Health Products and Food Branch Inspectorate
If you have any questions regarding this important information or for any medical inquiries on Merck Canada products, please call the Merck Canada Medical Information Centre at 514-428-8600 or 1-800-567-2594, or Health Canada at the number listed above.
original signed by
Mauricio Ede, M.D.
Executive Director, Medical Affairs
®Registered trademark of MSD International Holdings GmbH. Used under license.
1. ZENHALE® (mometasone furoate / formoterol fumarate dihydrate inhalation aerosol), Product Monograph, October 21, 2014
|02361744||ZENHALE® 50/5mcg 120 doses||1014439||June 2015|
|02361752||ZENHALE® 100/5mcg 120 doses||1073690||September 2015|
|ZENHALE® 100/5mcg 120 doses samples||1129736||October 2015|
|02361760||ZENHALE® 200/5mcg 120 doses||1057902||February 2016|
|ZENHALE® 200/5mcg 120 doses samples||1031232||December 2015|
For more informationThe manufacturer advised Health Canada of the risk associated with this health product, and has recalled the impacted product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.
- Date modified: