Sandoz-Irbesartan Product Recall (2021-05-27)
- Starting date:
- May 27, 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-75701
Last updated: 2021-05-31
Summary
-
Product:
- Sandoz Irbesartan 150mg Tablet
- Sandoz Irbesartan 300mg Tablet
-
Sandoz Irbesartan 150mg Tablet
-
Sandoz Irbesartan 300mg 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
Affected products
A. Sandoz Irbesartan 150mg Tablet
DIN, NPN, DIN-HIM
DIN 02328488Dosage form
Tablet
Strength
Irbesartan 150mg
Lot or serial number
KC7216
Companies
- Recalling Firm
-
Sandoz Canada Inc
110 de Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Inc
110 de Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
B. Sandoz Irbesartan 300mg Tablet
DIN, NPN, DIN-HIM
DIN 02328496Dosage form
Tablet
Strength
Irbesartan 300mg
Lot or serial number
KF8326
Companies
- Recalling Firm
-
Sandoz Canada Inc
110 de Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Inc
110 de Lauzon
Boucherville
J4B 1E6
Quebec
CANADA