Health product recall

Sandoz-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-75701



Last updated:
2021-05-31

Summary

  • Product:
    1. Sandoz Irbesartan 150mg Tablet
    2. Sandoz Irbesartan 300mg Tablet

  1. Sandoz Irbesartan 150mg Tablet

  2. Sandoz 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. Sandoz Irbesartan 150mg Tablet

DIN, NPN, DIN-HIM

DIN 02328488

Dosage form

Tablet

Strength

Irbesartan 150mg 

Lot or serial number

KC7216

Companies

Recalling Firm

Sandoz Canada Inc

110 de Lauzon

Boucherville

J4B 1E6

Quebec

CANADA

Marketing Authorization Holder

Sandoz Canada Inc

110 de Lauzon

Boucherville

J4B 1E6

Quebec

CANADA


B. Sandoz Irbesartan 300mg Tablet

DIN, NPN, DIN-HIM

DIN 02328496

Dosage form

Tablet

Strength

Irbesartan 300mg 

Lot or serial number

KF8326

Companies

Recalling Firm

Sandoz Canada Inc

110 de Lauzon

Boucherville

J4B 1E6

Quebec

CANADA

Marketing Authorization Holder

Sandoz Canada Inc

110 de Lauzon

Boucherville

J4B 1E6

Quebec

CANADA


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