Sanis 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-67518

Recalled Products

  1. Sanis Valsartan 40mg Tablet
  2. Sanis Valsartan 80mg Tablet
  3. Sanis Valsartan 160mg Tablet
  4. Sanis Valsartan 320mg Tablet

Reason

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

Depth of distribution

Retailers

Affected products

  1. Sanis Valsartan 40mg Tablet

DIN, NPN, DIN-HIM
DIN 02366940
Dosage form

Tablet

Strength

Valsartan 40mg

Lot or serial number

FZ9387, GB1869, GG3217, GJ6551, GS0243, GV2593, GX3220, GZ3841, HE2641, HF1652, HJ7307, HU1364, HW0232

Companies
Recalling Firm
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA
Marketing Authorization Holder
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA

B. Sanis Valsartan 80mg Tablet

DIN, NPN, DIN-HIM
DIN 02366959
Dosage form

Tablet

Strength

Valsartan 80mg

Lot or serial number

FT8503, FW5182, GA2771, GC7793, GG7745, GJ1684, GS0281, GS5743, GU9916, GZ4337, HC7983, HE2634, HJ3709, HK0311, HS3369, HX6740

Companies
Recalling Firm
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA
Marketing Authorization Holder
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA

C. Sanis Valsartan 160mg Tablet

DIN, NPN, DIN-HIM
DIN 02366967
Dosage form

Tablet

Strength

Valsartan 160mg

Lot or serial number

FS1098, FS6996, FU9241, FW5916, FZ0493, GB1894, GC7797, GJ6612, GP0036, GS5741, GV2589, GZ4345, HC7978, HF9786, HH0282, HP5436, HR4799, HS2689, HU9665

Companies
Recalling Firm
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA
Marketing Authorization Holder
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA

D. Sanis Valsartan 320mg Tablet

DIN, NPN, DIN-HIM
DIN 02366975
Dosage form

Tablet

Strength

Valsartan 320mg

Lot or serial number

FY0330, GD0242, GL0302, GS1215, GU9920, GZ7132, HB3853, HG1840, HJ1015, HS3372, HW4967

Companies
Recalling Firm
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA
Marketing Authorization Holder
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA

For more information

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