MINT-Irbesartan/HCTZ Product Recall (2021-05-26)
- Starting date:
- May 26, 2021
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75697
Last updated:
2021-05-31
Summary
-
Product:
- MINT-Irbesartan/HCTZ 150/12.5 mg Tablet
- MINT-Irbesartan/HCTZ 300/12.5 mg Tablet
- MINT-Irbesartan/HCTZ 300/25 mg Tablet
-
MINT-Irbesartan/HCTZ 150/12.5 mg Tablet
-
MINT-Irbesartan/HCTZ 300/12.5 mg Tablet
-
MINT-Irbesartan/HCTZ 300/25 mg Tablet
Reason
Presence of impurity 5-(4-(azidomethyl)-[1,1-biphenyl]-2-yl)-1H-tetrazole above the acceptable concentration limit in affected lots.
Depth of distribution
Retailers, Wholesalers
Affected products
A. MINT-Irbesartan/HCTZ 150/12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02392992
Dosage form
Tablet
Strength
Irbesartan 150 mg
Hydrochlorothiazide 12.5 mg
Lot or serial number
1805011398
Companies
- Recalling Firm
-
Mint Pharmaceuticals Inc
6575 Davand Drive
Mississauga
L5T 2M3
Ontario
CANADA
- Marketing Authorization Holder
-
Mint Pharmaceuticals Inc
6575 Davand Drive
Mississauga
L5T 2M3
Ontario
CANADA
B. MINT-Irbesartan/HCTZ 300/12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02393018
Dosage form
Tablet
Strength
Irbesartan 300 mg
Hydrochlorothiazide 12.5 mg
Lot or serial number
1805011402
Companies
- Recalling Firm
-
Mint Pharmaceuticals Inc
6575 Davand Drive
Mississauga
L5T 2M3
Ontario
CANADA
- Marketing Authorization Holder
-
Mint Pharmaceuticals Inc
6575 Davand Drive
Mississauga
L5T 2M3
Ontario
CANADA
C. MINT-Irbesartan/HCTZ 300/25 mg Tablet
DIN, NPN, DIN-HIM
DIN 02393026
Dosage form
Tablet
Strength
Irbesartan 300 mg
Hydrochlorothiazide 25 mg
Lot or serial number
1805011576
Companies
- Recalling Firm
-
Mint Pharmaceuticals Inc
6575 Davand Drive
Mississauga
L5T 2M3
Ontario
CANADA
- Marketing Authorization Holder
-
Mint Pharmaceuticals Inc
6575 Davand Drive
Mississauga
L5T 2M3
Ontario
CANADA