Health product recall

Sanofi-Aventis Avalide Product Recall(2021-06-14)

Starting date:
June 14, 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-75849

Last updated: 2021-06-16

Summary

  • Product: A. Avalide 300-12.5 mg B. Avalide 150-12.5 mg

Reason

Presence of impurity 5-(4-(azidomethyl)-[1,1-biphenyl]-2-yl)-1H-tetrazole above the acceptable concentration
limit in affected lot.

Depth of distribution

Retailers, Other (healthcare practioners)

Affected products

A. Avalide 300-12.5 mg

DIN, NPN, DIN-HIM

DIN 02241819

Dosage form

Tablet

Strength

Irbesartan 300 mg
Hydrochlorothiazide 12.5 mg

Lot or serial number

FT01644

Companies

Recalling Firm
Sanofi-Aventis Canada Inc.
2905 Place Louis.R-Renaud
Laval
H7V 0A3
Quebec
CANADA
Marketing Authorization Holder
Sanofi-Aventis Canada Inc.
2905 Place Louis.R-Renaud
Laval
H7V 0A3
Quebec
CANADA

B. Avalide 150-12.5 mg

DIN, NPN, DIN-HIM

DIN 02241818

Dosage form

Tablet

Strength

Irbesartan 150 mg
Hydrochlorothiazide 12.5 mg

Lot or serial number

ET02879, FT01327

Companies

Recalling Firm
Sanofi-Aventis Canada Inc.
2905 Place Louis.R-Renaud
Laval
H7V 0A3
Quebec
CANADA
Marketing Authorization Holder
Sanofi-Aventis Canada Inc.
2905 Place Louis.R-Renaud
Laval
H7V 0A3
Quebec
CANADA

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