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Zenhale Recall (2015-02-26)
- Starting date:
- February 26, 2015
- Posting date:
- March 9, 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-52483
Recalled Products
A. Zenhale 50
B. Zenhale 100
C. Zenhale 200
Reason
Product 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, Pharmacy, Physician
Affected products
A. Zenhale 50
DIN, NPN, DIN-HIM
DIN 02361744
Dosage form
Aerosol, Metered Dose
Strength
Formoterol Fumarate Dihydrate 5 mcg/dose
Mometasone Furoate 50 mcg/dose
Lot or serial number
1014439
1010247
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 100
DIN, NPN, DIN-HIM
DIN 02361752
Dosage form
Aerosol, Metered Dose
Strength
Formoterol Fumarate Dihydrate 5 mcg/dose
Mometasone Furoate 100 mcg/dose
Lot or serial number
932702
970946
1011672
1031209
1034145
1052117
1061619
1070764
1073690
1011676
1014427
1034146
1052043
1056057
1084790
1129736
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
C. Zenhale 200
DIN, NPN, DIN-HIM
DIN 02361760
Dosage form
Aerosol, Metered Dose
Strength
Formoterol Fumarate Dihydrate 5 mcg/dose
Mometasone Furoate 200 mcg/dose
Lot or serial number
873905
980452
1011673
1011674
1016321
1016660
1023002
1033618
1051407
1057902
937459
1014433
1016320
1028593
1031232
1043770
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