Health product recall

SANIS VALSARTAN (2021-05-21)

Starting date:
May 21, 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-75675



Last updated:
2021-05-26

Summary

  • Product:
    SANIS VALSARTAN

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

SANIS VALSARTAN

DIN, NPN, DIN-HIM

DIN 02366967

Dosage form

Tablet

Strength

Valsartan 160mg

Lot or serial number

KT9597

Companies

Recalling Firm

Sanis Health Inc.

243 Consumers Road

North York

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Sanis Health Inc.

243 Consumers Road

North York

M2J 4W8

Ontario

CANADA