Health product recall

Pro Doc Irbesartan Product Recall (2021-05-26)

Starting date:
May 26, 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-75695

Last updated: 2021-05-31

Summary

  • Product:
    1. Pro Doc Irbesartan 75 mg Tablet
    2. Pro Doc Irbesartan 150 mg Tablet
    3. Pro Doc Irbesartan 300 mg Tablet
  1. Pro Doc Irbesartan 75 mg Tablet
  2. Pro Doc Irbesartan 150 mg Tablet
  3. Pro Doc Irbesartan 300 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 75 mg Tablet

DIN, NPN, DIN-HIM

DIN 02365197

Dosage form

Tablet

Strength

Irbesartan 75mg 

Lot or serial number

616518,619960, 622192,622193

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 150 mg Tablet

DIN, NPN, DIN-HIM

DIN 02365200

Dosage form

Tablet

Strength

Irbesartan 150mg 

Lot or serial number

617491, 618112, 624632, 624633, 630546

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 300 mg Tablet

DIN, NPN, DIN-HIM

DIN 02365219

Dosage form

Tablet

Strength

Irbesartan 300mg 

Lot or serial number

615929, 617091, 617264, 620694, 624189, 624190, 624191, 624192

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