Recall Details


Start Date
2021-10-13
Categories
Health Products

Summary

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


Summary

Product: A. PMS-Losartan 25mg B. PMS-Losartan 50mg C. PMS-Losartan 100mg


Introduction

A. PMS-Losartan 25mg

B. PMS-Losartan 50mg

C. PMS-Losartan 100mg


Reason

Presence of impurity (5-[4'-[(5-(Azidomethyl)-2-butyl-4-chloro-1H-imidazol-1-yl)methyl]-[1,1'-biphenyl]-2-yl]-1H-tetrazole) above the acceptable concentration limit in affected lots


Depth of distribution

Retailers


A. PMS-Losartan 25mg

Brand name: A. PMS-Losartan 25mg
Dosage form: Tablet 
Strength: Losartan Potassium 25mg
DIN, NPN, DIN-HIM: DIN 02309750
Lot or serial number: 629303, 636356
Companies:

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


B. PMS-Losartan 50mg

Brand name: B. PMS-Losartan 50mg
Dosage form: Tablet 
Strength: Losartan Potassium 50mg
DIN, NPN, DIN-HIM: DIN 02309769
Lot or serial number: 629302, 636348, 636357
Companies:

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


C. PMS-Losartan 100mg

Brand name: C. PMS-Losartan 100mg
Dosage form: Tablet 
Strength: Losartan Potassium 100mg
DIN, NPN, DIN-HIM: DIN 02309777
Lot or serial number: 629306, 629307,636346,636358
Companies:

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


For more information

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75715a-eng.php


Identification number

Identification number: RA-76645