Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

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
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals, General Public
Identification number:
RA-43927

   

This is duplicated text of a letter from Merck Canada Inc. prepared in collaboration with Health Canada.

Audience

Patients affected and Health Professionals working in the following settings: Respirology, Internal Medicine, Family Practice, Pediatrics, Allergy, Pharmacy, Emergency Medicine.

Key messages

  • 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.

                                   

Issue

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.

Products affected

ZENHALE® (mometasone furoate/fomoterol fumarate dihydrate)

Refer to the list of lots at the end of this communication.

Background information

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
Fax: 1-800-369-3090

Merck Canada Inc. Medical Information Centre
Tel: 514-428-8600 or 1-800-567-2594
Fax: 514-428-8675 or 1-877-428-8675
Email: medinfocanada@merck.com

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 
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

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.

Sincerely,

original signed by

Mauricio Ede, M.D.
Executive Director, Medical Affairs

®Registered trademark of MSD International Holdings GmbH. Used under license.

References

1.    ZENHALE® (mometasone furoate / formoterol fumarate dihydrate inhalation aerosol), Product Monograph, October 21, 2014

 

Lots of ZENHALE® subject to recall
DIN DESCRIPTION LOT EXPIRATION DATE
02361744 ZENHALE® 50/5mcg 120 doses 1014439 June 2015
1010247 June 2015
02361752 ZENHALE® 100/5mcg 120 doses 1073690 September 2015
1011672 June 2015
1034145 June 2015
970946 March 2015
1052117 September 2015
1061619 September 2015
1070764 September 2015
1031209 September 2015
932702 February 2015
ZENHALE® 100/5mcg 120 doses samples 1129736 October 2015
1014427 June 2015
1011676 June 2015
1052043 August 2015
1034146 September 2015
1056057 September 2015
1084790 September 2015
02361760 ZENHALE® 200/5mcg 120 doses 1057902 February 2016
1023002 February 2016
873905 September 2015
980452 June 2015
1011673 September 2015
1016660 September 2015
1033618 October 2015
1016321 October 2015
1051407 October 2015
1011674 December 2015
ZENHALE® 200/5mcg 120 doses samples 1031232 December 2015
1014433 September 2015
1028593 October 2015
1043770 December 2015
937459 April 2015
1016320 October 2015

 

For more information

The 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.