Pro Doc Irbesartan Product Recall (2021-05-26)
- Starting date:
- May 26, 2021
- 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-75695
Last updated:
2021-05-31
Summary
-
Product:
- Pro Doc Irbesartan 75 mg Tablet
- Pro Doc Irbesartan 150 mg Tablet
- Pro Doc Irbesartan 300 mg Tablet
- Pro Doc Irbesartan 75 mg Tablet
- Pro Doc Irbesartan 150 mg Tablet
- Pro Doc Irbesartan 300 mg Tablet
Reason
Presence of impurity 5-(4-(azidomethyl)-[1,1-biphenyl]-2-yl)-1H-tetrazole above the acceptable concentration limit in affected lots.
Depth of distribution
Retailers
Affected products
A. Pro Doc Irbesartan 75 mg Tablet
DIN, NPN, DIN-HIM
DIN 02365197
Dosage form
Tablet
Strength
Irbesartan 75mg
Lot or serial number
616518,619960, 622192,622193
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. Pro Doc Irbesartan 150 mg Tablet
DIN, NPN, DIN-HIM
DIN 02365200
Dosage form
Tablet
Strength
Irbesartan 150mg
Lot or serial number
617491, 618112, 624632, 624633, 630546
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. Pro Doc Irbesartan 300 mg Tablet
DIN, NPN, DIN-HIM
DIN 02365219
Dosage form
Tablet
Strength
Irbesartan 300mg
Lot or serial number
615929, 617091, 617264, 620694, 624189, 624190, 624191, 624192
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