Health product recall

Sivem-Irbesartan/HCT 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-75691

Last updated: 2021-05-31

Summary

  • Product:
    1. Sivem-Irbesartan/HCT 150/12.5 mg Tablet
    2. Sivem-Irbesartan/HCT 300/12.5 mg Tablet
    3. Sivem-Irbesartan/HCT 300/25 mg Tablet
  1. Sivem-Irbesartan/HCT 150/12.5 mg Tablet
  2. Sivem-Irbesartan/HCT 300/12.5 mg Tablet
  3. Sivem-Irbesartan/HCT 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

Affected products

  1. Sivem-Irbesartan/HCT 150/12.5 mg Tablet

DIN, NPN, DIN-HIM

DIN 02385317

Dosage form

Tablet

Strength

  • Irbesartan 150 mg
  • Hydrochlorothiazide 12.5 mg

Lot or serial number

JN5054, JV2163, JY7867,KT2519, KT2520

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/HCT 300/12.5 mg Tablet

DIN, NPN, DIN-HIM

DIN 02385325

Dosage form

Tablet

Strength

Irbesartan 300 mg
Hydrochlorothiazide 12.5 mg

Lot or serial number

JP2979, JP2980, JU8206, JU8207

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

C. Sivem-Irbesartan/HCT 300/25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02385333

Dosage form

Tablet

Strength

Irbesartan 300 mg
Hydrochlorothiazide 25 mg

Lot or serial number

JX8881, JX8882, JB0216

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