Auro-Irbesartan HCT Tablet (2019-04-17)
- Starting date:
- April 17, 2019
- 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-69678
Last updated: 2019-04-23
Summary
-
Product:
Auro-Irbesartan HCT Tablet
Reason
Affected lot was found to contain NDEA at a level exceeding the acceptable limit
Depth of distribution
Retailers
Affected products
Auro-Irbesartan HCT Tablet
DIN, NPN, DIN-HIM
DIN 02447878
Dosage form
Tablet
Strength
Hydrochlorothiazide 12.5 mg
Irbesartan 150 mg
Lot or serial number
1518001-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