Apotex Losartan Product Recall (2019-03-08)
- Starting date:
- March 8, 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-69278
Recalled Products
- APO-Losartan 25mg Tablet
- APO-Losartan 50mg Tablet
- APO-Losartan 100mg Tablet
- APO-Losartan / HCTZ 50/12.5 mgTablet
- APO-Losartan / HCTZ 100/12.5 mgTablet
- APO-Losartan / HCTZ 100/25 mgTablet
Reason
Affected lots manufactured with an API that may contain the impurity N-nitroso-N-methyl-4-aminobutyric acid (referred as “NMBA”) above the acceptable level.
Depth of distribution
Retailers
Affected products
A. APO-Losartan 25mg Tablet
DIN, NPN, DIN-HIM
DIN 02379058
Dosage form
Tablet
Strength
Losartan potassium 25mg
Lot or serial number
NL1453, NL1452
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
B. APO-Losartan 50mg Tablet
DIN, NPN, DIN-HIM
DIN 02353504
Dosage form
Tablet
Strength
Losartan potassium 50mg
Lot or serial number
NK1254, NK1253
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
C. APO-Losartan 100mg Tablet
DIN, NPN, DIN-HIM
DIN 02353512
Dosage form
Tablet
Strength
Losartan potassium 100mg
Lot or serial number
NL1461, NG2092, NH5932, NH5933, NL1460, NH5934
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
D. APO-Losartan / HCTZ 50/12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02371235
Dosage form
Tablet
Strength
Hydrochlorothiazide 12.5mg
Losartan potassium 50.0mg
Lot or serial number
NL1441, NZ8848, NL1445, NZ8849, NZ8860
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
E. APO-Losartan / HCTZ 100/12.5 mg Tablet
DIN, NPN, DIN-HIM
DIN 02371243
Dosage form
Tablet
Strength
Hydrochlorothiazide 12.5mg
Losartan potassium 100mg
Lot or serial number
NG2087, NL1421, NG2086, NL1422
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
F. APO-Losartan / HCTZ 100/25 mg Tablet
DIN, NPN, DIN-HIM
DIN 02371251
Dosage form
Tablet
Strength
Hydrochlorothiazide 25mg
Losartan potassium 100mg
Lot or serial number
NL1429, NZ8846, NZ8847, NZ8845
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA