Health product recall

Pharmascience PMS-Losartan product recall (2021-10-13)

Starting date:
October 13, 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-76645

Last updated: 2021-10-15

Summary

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

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

Affected products

A. PMS-Losartan 25mg

DIN, NPN, DIN-HIM

DIN 02309750

Dosage form

Tablet 

Strength

Losartan Potassium 25mg

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

DIN, NPN, DIN-HIM

DIN 02309769

Dosage form

Tablet 

Strength

Losartan Potassium 50mg

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

DIN, NPN, DIN-HIM

DIN 02309777

Dosage form

Tablet 

Strength

Losartan Potassium 100mg

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