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
- Losartan 25mg Tablet
- Losartan 50mg Tablet
- 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