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