Health product recall

Sivem-Irbesartan 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-75689

Last updated: 2021-05-31

Summary

  • Product:
    1. Sivem-Irbesartan 150 mg Tablet
    2. Sivem-Irbesartan 300 mg Tablet
  1. Sivem-Irbesartan 150 mg Tablet
  2. Sivem-Irbesartan 300 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

Affected products

  1. Sivem-Irbesartan 150 mg Tablet

DIN, NPN, DIN-HIM

DIN 02385295

Dosage form

Tablet

Strength

Irbesartan 150mg

Lot or serial number

KC7215

Companies

Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA

B. Sivem-Irbesartan 300 mg Tablet

DIN, NPN, DIN-HIM

DIN 02385309

Dosage form

Tablet

Strength

Irbesartan 300mg

Lot or serial number

KF8325

Companies

Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA

Date modified: