Pro Doc Irbesartan/HCTZ Product Recall (2021-05-27) | Recall Monitor

Pro Doc Irbesartan/HCTZ Product Recall (2021-05-27)
Health Products
May 27th, 2021 @ 12:00 AM

Basic Details

Issue: Product Safety
Category: Drugs
Audience: General Public, Healthcare Professionals, Hospitals
Department: Health Canada
Hazard classification: Type I
Alert type: Drug Recall

Summary

Product

Pro Doc Irbesartan/HCTZ 150 mg/12.5 mg Tablet

Products

Lot or serial numberBrand nameCompaniesDIN, NPN, DIN-HIMDosage formStrength
JR7823, JR7824, JU7506B. Pro Doc Irbesartan/HCTZ 300 mg/12.5 mg Tablet
Recalling Firm
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
Marketing Authorization Holder
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
DIN 02365170TabletIrbesartan 300 mg
JS0731C. Pro Doc Irbesartan/HCTZ  300 mg/25 mg Tablet
Recalling Firm
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
Marketing Authorization Holder
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
DIN 02365189TabletIrbesartan 300 mg
JN4976, JU3231, JY1913A. Pro Doc Irbesartan/HCTZ 150 mg/12.5 mg Tablet
Recalling Firm
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
Marketing Authorization Holder
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
DIN 02365162TabletIrbesartan 150 mg

Introduction

  1. Pro Doc Irbesartan/HCTZ 150 mg/12.5 mg Tablet

  2. Pro Doc Irbesartan/HCTZ 300 mg/12.5 mg Tablet

  3. Pro Doc Irbesartan/HCTZ  300 mg/25 mg 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 

For more information

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