Sandoz Canada Losartan/Losartan-HCT Product Recall (2021-09-13)
- Starting date:
- September 13, 2021
- Posting date:
- September 16, 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-76435
Last updated:
2021-09-16
Summary
-
Product:
- Losartan 25 mg Tablet
- Losartan 50 mg Tablet
- Losartan 100 mg Tablet
- Losartan/HCT 50 mg / 12.5 mg Tablet
- Losartan/HCT 100 mg / 12.5 mg Tablet
- Losartan/HCT 100 mg / 25 mg Tablet
- Losartan 25 mg Tablet
- Losartan 50 mg Tablet
- Losartan 100 mg Tablet
- Losartan/HCT 50 mg / 12.5 mg Tablet
- Losartan/HCT 100 mg / 12.5 mg Tablet
- Losartan/HCT 100 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
Losartan 25 mg Tablet
DIN, NPN, DIN-HIM
DIN 02313332
Dosage form
Tablet
Strength
Losartan Potassium 25 mg
Lot or serial number
KF3703, KF3704, KR0055, KS3238, KV8085, KY3612
Companies
- Recalling Firm
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
Losartan 50 mg Tablet
DIN, NPN, DIN-HIM
DIN 02313340
Dosage form
Tablet
Strength
Losartan Potassium 50 mg
Lot or serial number
KF3629, KS1008, KS1009, KS8837, KT8356, KY8356, KY7473, KS1006, KY7472
Companies
- Recalling Firm
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
Losartan 100 mg Tablet
DIN, NPN, DIN-HIM
DIN 02313359
Dosage form
Tablet
Strength
Losartan Potassium 25 mg
Lot or serial number
KF3630, KR6172, KS7551, LA1962, LD1621, LJ2275, KR6171, LA0665
Companies
- Recalling Firm
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
Losartan/HCT 50 mg / 12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02313375
Dosage form
Tablet
Strength
Hydrochlorothiazide 12.5 mg, Losartan Potassium 50 mg
Lot or serial number
KF3705, KF3706, KR8908, KS7564, KX6497, LB3649, KR7041, KS5626, KS5627, KX6500
Companies
- Recalling Firm
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
Losartan/HCT 100 mg / 12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02362449
Dosage form
Tablet
Strength
Hydrochlorothiazide 12.5 mg, Losartan Potassium 100 mg
Lot or serial number
KF3628, KS3893, KT2043, KY9842, LB1657, KF3714, KS3889, KS3890, KT2044, KY9846
Companies
- Recalling Firm
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Incorporated
110 Rue De Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
Losartan/HCT 100 mg / 25 mg Tablet
DIN, NPN, DIN-HIM
DIN 02313383
Dosage form
Tablet
Strength
Hydrochlorothiazide 25 mg, Losartan Potassium 100 mg
Lot or serial number
KG4858, KU3078, KS3076, KZ7522, KG4859, KS3077, KZ7520
Companies
- Recalling Firm
-
Sandoz Canada Inc
110 de Lauzon
Boucherville
J4B 1E6
Quebec
CANADA
- Marketing Authorization Holder
-
Sandoz Canada Inc
110 de Lauzon
Boucherville
J4B 1E6
Quebec
CANADA