Health product recall

Sandoz Irbesartan HCT(2021-01-12)

Starting date:
January 12, 2021
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74779

Last updated: 2021-01-20

Summary

  • Product: Sandoz Irbesartan HCT

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

Sandoz Irbesartan HCT

DIN, NPN, DIN-HIM

DIN 02337436

Dosage form

Tablet

Strength

  • Hydrochlorothiazide 12.5mg
  • Irbesartan 300mg

Lot or serial number

  • HY7383
  • JA4033
  • JA4034
  • JE2529

Companies

Recalling Firm
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
Marketing Authorization Holder
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA

Date modified: