Pro Doc 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-69322

Recalled Products

  1. Losartan 25mg Tablet
  2. Losartan 50mg Tablet
  3. 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. Losartan 25mg Tablet

DIN, NPN, DIN-HIM
DIN 02394367
Dosage form

Tablet

Strength

Losartan potassium 25mg

Lot or serial number

498292, 605344

Companies
Recalling Firm
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
Marketing Authorization Holder
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA

B. Losartan 50mg Tablet

DIN, NPN, DIN-HIM
DIN 02394375
Dosage form

Tablet

Strength

Losartan potassium 50mg

Lot or serial number

498779, 600046, 603903, 498284, 603895

Companies
Recalling Firm
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
Marketing Authorization Holder
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA

C. Losartan 100mg Tablet

DIN, NPN, DIN-HIM
DIN 02394383
Dosage form

Tablet

Strength

Losartan potassium 100mg

Lot or serial number

499008, 605299, 605297

Companies
Recalling Firm
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
Marketing Authorization Holder
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA