RAN-Irbesartan 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-75733
Last updated:
2021-06-01
Summary
-
Product:
A. RAN- Irbesartan 75mg TabletB. RAN- Irbesartan 150mg Tablet
C. RAN- Irbesartan 300mg Tablet
A. RAN- Irbesartan 75mg Tablet
B. RAN- Irbesartan 150mg Tablet
C. RAN- Irbesartan 300mg 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. RAN- Irbesartan 75mg Tablet
DIN, NPN, DIN-HIM
DIN 02406810
Dosage form
Tablet
Strength
Irbesartan 75mg
Lot or serial number
- AB47143,
- AB58473,
- AB58829,
- 3994101
Companies
- Recalling Firm
-
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA
- Marketing Authorization Holder
-
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA
B. RAN- Irbesartan 150mg Tablet
DIN, NPN, DIN-HIM
DIN 02406829
Dosage form
Tablet
Strength
Irbesartan 150mg
Lot or serial number
- AB47146,
- AB47147,
- AB47148,
- AB57691,
- AB57688,
- AB57689,
- AB58827,
- 3990655
Companies
- Recalling Firm
-
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA
- Marketing Authorization Holder
-
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA
C. RAN- Irbesartan 300mg Tablet
DIN, NPN, DIN-HIM
DIN 02406837
Dosage form
Tablet
Strength
Irbesartan 300mg
Lot or serial number
- AB47144,
- AB47145,
- AB58305,
- AB58312,
- AB58314,
- AB58828,
- AB57696,
- AB58304
- AB70496,
- AB70498,
- AB70499,
- 3991358,
- 3991360
Companies
- Recalling Firm
-
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA
- Marketing Authorization Holder
-
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA