Health product recall

Losartan (2021-08-27)

Starting date:
August 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-76345

Last updated:
2021-08-30

Summary

  • Product:
    Losartan

Reason

Presence of impurity (5-[4'-[(5-(Azidomethyl)-2-butyl-4-chloro-1H-imidazol-1-yl) methyl]-[1,1'-biphenyl]-2-yl]-1H-tetrazole) above the acceptable concentration limit in affected lots.

Affected products

Losartan

DIN, NPN, DIN-HIM

DIN 02388804

Dosage form

Tablet 

Strength

Losartan Potassium 50mg 

Lot or serial number

1010419, 1020419

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