PMS-Irbesartan Product Recall (2021-05-25)
- Starting date:
- May 25, 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-75683
Last updated:
2021-05-31
Summary
-
Product:
- PMS-Irbesartan 75 mg Tablet
- PMS-Irbesartan 150 mg Tablet
- PMS-Irbesartan 75 mg Tablet
- PMS-Irbesartan 150 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
-
PMS-Irbesartan 75 mg Tablet
DIN, NPN, DIN-HIM
DIN 02317060
Dosage form
Tablet
Strength
Irbesartan 75 mg
Lot or serial number
617466, 617467, 617468, 620272, 622195, 624738
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-Irbesartan 150 mg Tablet
DIN, NPN, DIN-HIM
DIN 02317079
Dosage form
Tablet
Strength
Irbesartan 150 mg
Lot or serial number
617492, 624634, 630661
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