Health product recall

Teva Valsartan/HCTZ Product Recall (2018-08-17)

Starting date:
August 17, 2018
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-67558

Recalled Products

  1. Teva-Valsartan/HCTZ 80mg/12.5mg Tablet
  2. Teva-Valsartan/HCTZ 160mg/12.5mg Tablet
  3. Teva-Valsartan/HCTZ 320mg/12.5mg Tablet
  4. Teva-Valsartan/HCTZ 160mg/25mg Tablet

Reason

Affected lots may be manufactured with an API containing a contaminant.

Depth of distribution

Retailers

Affected products

A. Teva-Valsartan/HCTZ 80mg/12.5mg Tablet

DIN, NPN, DIN-HIM
DIN 02356996
Dosage form

Tablet

Strength

Valsartan 80mg
Hydrochlorothiazide 12.5mg

Lot or serial number

35211136A

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

B. Teva-Valsartan/HCTZ 160mg/12.5mg Tablet

DIN, NPN, DIN-HIM
DIN 02357003
Dosage form

Tablet

Strength

Valsartan 160mg
Hydrochlorothiazide 12.5mg

Lot or serial number

35211335A, 35211844R

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

C. Teva-Valsartan/HCTZ 320mg/12.5mg Tablet

DIN, NPN, DIN-HIM
DIN 02357003
Dosage form

Tablet

Strength

Valsartan 320mg
Hydrochlorothiazide 12.5mg

Lot or serial number

35211546R

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

D. Teva-Valsartan/HCTZ 160mg/25mg Tablet

DIN, NPN, DIN-HIM
DIN 02357011
Dosage form

Tablet

Strength

Valsartan 160mg
Hydrochlorothiazide 25mg

Lot or serial number

35210937R, 35210938R, 35210393R, 35210940R

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

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