Health product recall

PMS-Irbesartan Product Recall (2021-05-25)

Starting date:
May 25, 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-75683

Last updated: 2021-05-31

Summary

  • Product:
    1. PMS-Irbesartan 75 mg Tablet
    2. PMS-Irbesartan 150 mg Tablet
  1. PMS-Irbesartan 75 mg Tablet
  2. PMS-Irbesartan 150 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

  1. PMS-Irbesartan 75 mg Tablet

DIN, NPN, DIN-HIM

DIN 02317060

Dosage form

Tablet

Strength

Irbesartan 75 mg  

Lot or serial number

617466, 617467, 617468, 620272, 622195, 624738

Companies

Recalling Firm
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montreal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montreal
H4P 2T4
Quebec
CANADA

B. PMS-Irbesartan 150 mg Tablet

DIN, NPN, DIN-HIM

DIN 02317079

Dosage form

Tablet

Strength

Irbesartan 150 mg  

Lot or serial number

617492, 624634, 630661

Companies

Recalling Firm
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montreal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montreal
H4P 2T4
Quebec
CANADA