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Health Canada Health products

ZENHALE (mometasone furoate/formoterol fumarate dihydrate inhalation aerosol) - Recalled Lots Due to the Possibility of Device Malfunction After 24 Months Shelf-Life

Issued February 27, 2015
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.
Hazard description
Product safety