Sandoz Irbesartan HCT(2021-01-12)
- Starting date:
- January 12, 2021
- 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-74779
Last updated:
2021-01-20
Summary
-
Product:
Sandoz Irbesartan HCT
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
Affected products
Sandoz Irbesartan HCT
DIN, NPN, DIN-HIM
DIN 02337436
Dosage form
Tablet
Strength
- Hydrochlorothiazide 12.5mg
- Irbesartan 300mg
Lot or serial number
- HY7383
- JA4033
- JA4034
- JE2529
Companies
- Recalling Firm
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA