Pro Doc Irbesartan/HCTZ Product Recall (2021-05-27)
- Starting date:
- May 27, 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-75705
Last updated:
2021-05-31
Summary
-
Product:
- Pro Doc Irbesartan/HCTZ 150 mg/12.5 mg Tablet
- Pro Doc Irbesartan/HCTZ 300 mg/12.5 mg Tablet
- Pro Doc Irbesartan/HCTZ 300 mg/25 mg Tablet
-
Pro Doc Irbesartan/HCTZ 150 mg/12.5 mg Tablet
-
Pro Doc Irbesartan/HCTZ 300 mg/12.5 mg Tablet
-
Pro Doc Irbesartan/HCTZ 300 mg/25 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/HCTZ 150 mg/12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02365162
Dosage form
Tablet
Strength
Irbesartan 150 mg
Hydrochlorothiazide 12.5 mg
Lot or serial number
JN4976, JU3231, JY1913
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/HCTZ 300 mg/12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02365170
Dosage form
Tablet
Strength
Irbesartan 300 mg
Hydrochlorothiazide 12.5 mg
Lot or serial number
JR7823, JR7824, JU7506
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/HCTZ 300 mg/25 mg Tablet
DIN, NPN, DIN-HIM
DIN 02365189
Dosage form
Tablet
Strength
Irbesartan 300 mg
Hydrochlorothiazide 25 mg
Lot or serial number
JS0731
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