Pro Doc Irbesartan Product Recall (2019-03-11)
- Starting date:
- March 11, 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-69330
Recalled Products
- Irbesartan 150mg Tablet
- Irbesartan 300mg Tablet
Reason
Affected lots manufactured with an API that contains the impurity N-nitrosodiéthylamine (otherwise known as “ndea”) above the acceptable level.
Depth of distribution
Retailers, Wholesalers
Affected products
A. Irbesartan 150mg Tablet
DIN, NPN, DIN-HIM
DIN 02365200
Dosage form
Tablet
Strength
Irbesartan 150mg
Lot or serial number
604292
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. Irbesartan 300mg Tablet
DIN, NPN, DIN-HIM
DIN 02365219
Dosage form
Tablet
Strength
Irbesartan 300mg
Lot or serial number
601795
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