Health product recall

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