Teva Valsartan Product Recall (2018-07-09)

Starting date:
July 9, 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-67514

Recalled Products

  1. ACT-Valsartan 40mg Tablet
  2. ACT-Valsartan 80mg Tablet
  3. ACT-Valsartan 160mg Tablet
  4. ACT-Valsartan 320mg Tablet
  5. Teva-Valsartan / HCTZ Tablet

Reason

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

Depth of distribution

Retailers

Affected products

  1. ACT-Valsartan 40mg Tablet

DIN, NPN, DIN-HIM
DIN 02337487
Dosage form

Tablet

Strength

Valsartan 40mg

Lot or serial number

K47338

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. ACT-Valsartan 80mg Tablet

DIN, NPN, DIN-HIM
DIN 02337495
Dosage form

Tablet

Strength

Valsartan 80mg

Lot or serial number

K45370, K47652, K47653, K47654

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. ACT-Valsartan 160mg Tablet

DIN, NPN, DIN-HIM
DIN 02337509
Dosage form

Tablet

Strength

Valsartan 160mg

Lot or serial number

K44167, K39691, K47657, K47658

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. ACT-Valsartan 320mg Tablet

DIN, NPN, DIN-HIM
DIN 02337517
Dosage form

Tablet

Strength

Valsartan 320mg

Lot or serial number

K44166, K45371

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

E. Teva-Valsartan / HCTZ Tablet

DIN, NPN, DIN-HIM
DIN 02357046
Dosage form

Tablet

Strength

Valsartan 320mg
Hydrochlorothiazide 25mg

Lot or serial number

35212731R

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

For more information

http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67202a-eng.php