Sivem 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-67512

Recalled Products

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

Reason

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

Depth of distribution

Retailers

Affected products

  1. Sivem-Valsartan 40mg Tablet

DIN, NPN, DIN-HIM
DIN 02384523
Dosage form

Tablet

Strength

Valsartan 40mg

Lot or serial number

FZ9383, GJ6502, HJ7305, GG3216, GX3218, GZ3842, HJ7308, HK0281

Companies
Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA

B. Sivem-Valsartan 80mg Tablet

DIN, NPN, DIN-HIM
DIN 02384531
Dosage form

Tablet

Strength

Valsartan 80mg

Lot or serial number

GC7791, GA2768, GS5744, GX1307, HB3338, HJ3708, HR6081

Companies
Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA

C. Sivem-Valsartan 160mg Tablet

DIN, NPN, DIN-HIM
DIN 02384558
Dosage form

Tablet

Strength

Valsartan 160mg

Lot or serial number

FS0240, FS7001, FY0325, HJ7928, FZ0492, GS0290, GX1312, GY6767, HF9785, HP5437

Companies
Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA

D. Sivem-Valsartan 320mg Tablet

DIN, NPN, DIN-HIM
DIN 02384566
Dosage form

Tablet

Strength

Valsartan 320mg

Lot or serial number

FU8269, HJ1012, HW4964, FY0331, GU9919, GX1302, HB3851, HG1841, HJ1016

Companies
Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA

For more information

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