Pharmascience Losartan Product Recall (2019-03-08)

Starting date:
March 8, 2019
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-69318

Recalled Products

  1. PMS-Losartan 25mg Tablet
  2. PMS-Losartan 50mg Tablet
  3. PMS-Losartan 100mg Tablet

Reason

Affected lots manufactured with an API that may contain the impurity N-nitroso-N-methyl-4-aminobutyric acid (referred as “NMBA”) above the acceptable level.

Depth of distribution

Retailers, Wholesalers

Affected products

A. PMS-Losartan 25mg Tablet

DIN, NPN, DIN-HIM
DIN 02309750
Dosage form

Tablet

Strength

Losartan potassium 25mg

Lot or serial number

498294, 605342, 611944

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-Losartan 50mg Tablet

DIN, NPN, DIN-HIM
DIN 02309769
Dosage form

Tablet

Strength

Losartan potassium 50mg

Lot or serial number

498285, 600047, 600091, 603894, 612025, 612031, 612679, 616743

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

C. PMS-Losartan 100mg Tablet

DIN, NPN, DIN-HIM
DIN 02309777
Dosage form

Tablet

Strength

Losartan potassium 100mg

Lot or serial number

498864, 602668, 603816, 605298, 605300, 613935, 613936

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