Health product recall

Pro Doc Irbesartan/HCTZ 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-75705

Last updated: 2021-05-31

Summary

  • Product:
    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
  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 

Affected products

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

DIN, NPN, DIN-HIM

DIN 02365162

Dosage form

Tablet

Strength

Irbesartan 150 mg
Hydrochlorothiazide 12.5 mg

Lot or serial number

JN4976, JU3231, JY1913

Companies

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

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

DIN, NPN, DIN-HIM

DIN 02365170

Dosage form

Tablet

Strength

Irbesartan 300 mg
Hydrochlorothiazide 12.5 mg

Lot or serial number

JR7823, JR7824, JU7506

Companies

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

C. Pro Doc Irbesartan/HCTZ  300 mg/25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02365189

Dosage form

Tablet

Strength

Irbesartan 300 mg
Hydrochlorothiazide 25 mg

Lot or serial number

JS0731

Companies

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