Sandoz-Valsartan 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-75703
Last updated:
2021-05-31
Summary
-
Product:
- Sandoz Valsartan 80mg Tablet
- Sandoz Valsartan 160mg Tablet
- Sandoz Valsartan 320mg Tablet
-
Sandoz Valsartan 80mg Tablet
-
Sandoz Valsartan 160mg Tablet
-
Sandoz Valsartan 320mg Tablet
- 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
- 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
- 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
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 Valsartan 80mg Tablet
DIN, NPN, DIN-HIM
DIN 02356759
Dosage form
Tablet
Strength
Valsartan 80mg
Lot or serial number
KT7180, KT9515
Companies
B. Sandoz Valsartan 160mg Tablet
DIN, NPN, DIN-HIM
DIN 02356767
Dosage form
Tablet
Strength
Valsartan 160mg
Lot or serial number
KT9598
Companies
C. Sandoz Valsartan 320mg Tablet
DIN, NPN, DIN-HIM
DIN 02356775
Dosage form
Tablet
Strength
Valsartan 320mg
Lot or serial number
KT8923, KV6185
Companies