TEVA-LOSARTAN/HCTZ (2019-03-06)
- Starting date:
- March 6, 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-69266
Recalled Products
Teva-Losartan / HCTZ 50/12.5mg Tablet
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
Teva-Losartan / HCTZ 50/12.5mg Tablet
DIN, NPN, DIN-HIM
DIN 02358263
Dosage form
Tablet
Strength
Hydrochlorothiazide 12.5mg
Losartan potassium 50.0mg
Lot or serial number
35344801A, 35349397A
Companies
- Recalling Firm
-
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA
- Marketing Authorization Holder
-
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA