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