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