Auro-Losartan Product Recall (2021-05-27)
- Starting date:
- May 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-75707
Last updated: 2021-05-31
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-(azidomethyl)-[1,1-biphenyl]-2-yl)-1H-tetrazole above the acceptable concentration limit in affected lots.
Depth of distribution
Retailers
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
WB2519001-A
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
WB5019001-A, WB5019001-B
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
WB1019001-A, WB1019001-B
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