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
- PMS-Losartan 25mg Tablet
- PMS-Losartan 50mg Tablet
- 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