Auro Pharma Losartan product recall (2021-10-01)
- Starting date:
- October 1, 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-76569
Last updated: 2021-10-04
Summary
-
Product:
- Auro-Losartan 25 mg Tablet
- Auro-Losartan 50 mg Tablet
- Auro-Losartan 100 mg Tablet
- Auro-Losartan 25 mg Tablet
- Auro-Losartan 50 mg Tablet
- Auro-Losartan 100 mg Tablet
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
A. Auro-Losartan 25 mg Tablet
DIN, NPN, DIN-HIM
DIN 02403323Dosage form
Tablet
Strength
Losartan Potassium 25 mg
Lot or serial number
AEJ2520001A
Companies
- Recalling Firm
-
Auro Pharma Inc.
3700 Steeles Ave. W
Woodbridge
L4L 8K8
Ontario
CANADA
- Marketing Authorization Holder
-
Auro Pharma Inc.
3700 Steeles Ave. W
Woodbridge
L4L 8K8
Ontario
CANADA
B. Auro-Losartan 50 mg Tablet
DIN, NPN, DIN-HIM
DIN 02403331Dosage form
Tablet
Strength
Losartan Potassium 50 mg
Lot or serial number
AEJ5020001A, AEJ5020002A, AEJ5020003A
Companies
- Recalling Firm
-
Auro Pharma Inc.
3700 Steeles Ave. W
Woodbridge
L4L 8K8
Ontario
CANADA
- Marketing Authorization Holder
-
Auro Pharma Inc.
3700 Steeles Ave. W
Woodbridge
L4L 8K8
Ontario
CANADA
C. Auro-Losartan 100 mg Tablet
DIN, NPN, DIN-HIM
DIN 02403358Dosage form
Tablet
Strength
Losartan Potassium 100 mg
Lot or serial number
AEJ1020001A, AEJ1020002A, AEJ1020003A
Companies
- Recalling Firm
-
Auro Pharma Inc.
3700 Steeles Ave. W
Woodbridge
L4L 8K8
Ontario
CANADA
- Marketing Authorization Holder
-
Auro Pharma Inc.
3700 Steeles Ave. W
Woodbridge
L4L 8K8
Ontario
CANADA