Health product recall

Sanofi-Aventis Avapro 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-75851

Last updated: 2021-06-16

Summary

  • Product: A. Avapro 75mg B. Avapro 150mg C. Avapro 300mg

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. Avapro 75mg

DIN, NPN, DIN-HIM

DIN 02237923

Dosage form

Tablet

Strength

Irbesartan 75 mg

Lot or serial number

FT00590

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. Avapro 150mg

DIN, NPN, DIN-HIM

DIN 02237924

Dosage form

Tablet

Strength

Irbesartan 150 mg

Lot or serial number

ET04153, FT01995, FT01238

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

C. Avapro 300mg

DIN, NPN, DIN-HIM

DIN 02237925

Dosage form

Tablet

Strength

Irbesartan 300 mg

Lot or serial number

FT00969, FT01225, FT01226, FT01999, FT04262

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

Report a problem or mistake on this page
What was wrong?

If you want to receive a follow-up reply, please include your name and e-mail address.

CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Date modified: