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Zenhale Product Recall (2015-06-30)
- Starting date:
- June 30, 2015
- Posting date:
- July 7, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54118
Recalled Products
- Zenhale 50 µg
- Zenhale 200 µg
Reason
Lots recalled 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.
Depth of distribution
Wholesalers, pharmacies and physicians
Affected products
A. Zenhale 50 µg
DIN, NPN, DIN-HIM
DIN 02361744Dosage form
Aerosol, Metered Dose
Strength
- Formoterol Fumarate Dihydrate 5 µg / dose
- Mometasone Furoate 50 µg / dose
Lot or serial number
- 1024249
Companies
- Recalling Firm
-
Merck Canada
16750 Trans Canada HWY
Kirkland
H9H 4M7
Quebec
CANADA
- Marketing Authorization Holder
-
Merck Canada
16750 Trans Canada HWY
Kirkland
H9H 4M7
Quebec
CANADA
B. Zenhale 200 µg
DIN, NPN, DIN-HIM
DIN 02361760Dosage form
Aerosol, Metered Dose
Strength
- Formoterol Fumarate Dihydrate 5 µg / dose
- Mometasone Furoate 200 µg / dose
Lot or serial number
- 1023003
- 1024248
- 1073696
- 1095940
- 1095941
Sample lots:
- 1056065
- 1056071
- 1087740
- 1092557
- 1092562
- 1128538
Companies
- Recalling Firm
-
Merck Canada
16750 Trans Canada HWY
Kirkland
H9H 4M7
Quebec
CANADA
- Marketing Authorization Holder
-
Merck Canada
16750 Trans Canada HWY
Kirkland
H9H 4M7
Quebec
CANADA