Health product recall

PMS-Irbesartan/HCTZ 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-75685

Last updated:
2021-05-31

Summary

  • Product:
    1. PMS-Irbesartan/HCTZ 300 mg/12.5 mg Tablet
    2. PMS-Irbesartan/HCTZ 300 mg/25 mg Tablet
  1. PMS-Irbesartan/HCTZ 300 mg/12.5 mg Tablet
  2. PMS-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

  1. PMS-Irbesartan/HCTZ 300 mg/12.5 mg Tablet

DIN, NPN, DIN-HIM

DIN 02328526

Dosage form

Tablet

Strength

  • Irbesartan 300 mg
  • Hydrochlorothiazide 12.5 mg

Lot or serial number

621822, 621823, 625902, 625318, 629920, 631052, 632583

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/HCTZ 300 mg/25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02328534

Dosage form

Tablet

Strength

Irbesartan 300 mg
Hydrochlorothiazide 25 mg

Lot or serial number

624235

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