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Sandoz Valsartan Product Recall (2018-07-09)

Report a Concern
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-67508

Recalled Products

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

Reason

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

Depth of distribution

Retailers

Affected products

  1. Sandoz-Valsartan 40mg Tablet

DIN, NPN, DIN-HIM
DIN 02356740
Dosage form

Tablet

Strength

Valsartan 40mg

Lot or serial number

GG3218, GJ6503, GS0241, GX3217, HB3316, HE2642, HH4576, HW0229, FZ9389, GB1871, GG3215, GG3215, GJ6550, GL2635, GS0244, GX3219, GZ3840, HE2639, HE2639, HF1653, HJ7309, HU1366, HW0231

Companies
Recalling Firm
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA
Marketing Authorization Holder
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA

B. Sandoz-Valsartan 80mg Tablet

DIN, NPN, DIN-HIM
DIN 02356759
Dosage form

Tablet

Strength

Valsartan 80mg

Lot or serial number

FT8501, GC7792, GS1135, GZ4340, HC7984, HG2490, HJ3705, FT8504, FW5181, FZ0477, GA2770, GC1748, GC7794, GG7743, GJ1683, GL2639, GL9742, GS0280, GS5745, GU9915, GX1306, GX1309, GZ4339, HC7982, HC7985, HE2633, HJ3702, HJ3707, HK0312, HM1543, HR9281, HX1997, HX1998, HX6746, FT8502, FZ0478, GC1749, GC7795, GJ1682, GL9743, GS1134, GU9917, GX1308, HB3335, HC7986, HG2488, HK0313, HM1544, HR6082, HS3370, HS8264, HV4515

Companies
Recalling Firm
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA
Marketing Authorization Holder
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA

C. Sandoz-Valsartan 160mg Tablet

DIN, NPN, DIN-HIM
DIN 02356767
Dosage form

Tablet

Strength

Valsartan 160mg

Lot or serial number

FW5917, FY0326, FY0327, GA2793, GB1895, GC1764, GG1243, GJ1686, GJ6611, GK9454, GL9769, GN4322, GP0034, GP0515, GS5739, GV2588, GX1311, GY6768, GZ4346, HC7979, HC7980, HC7987, HC7995, HF9787, HH0283, HH0283, HH6946, HR4798, HU3443, HU9666, HX6736, HX7637, HX7638, FU1588, FU9304, FV2951, GA2792, GC7796, GL9768, GP0033, GS0291, GS5742, GW2839, HC8785, HE2631, HH6945, HJ7930, HS2690, HY1416

Companies
Recalling Firm
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA
Marketing Authorization Holder
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA

D. Sandoz-Valsartan 320mg Tablet

DIN, NPN, DIN-HIM
DIN 02356775
Dosage form

Tablet

Strength

Valsartan 320mg

Lot or serial number

GC1791, HB3849, HP5427, HV6928, FU8262, FY0332, GA2820, GC1795, GD0243, GG3249, GL0300, GS1213, GU9918, GX1301, GZ7130, HG0581, HG1842, HJ1014, HP5426, HS3371, HV6930, HW4965

Companies
Recalling Firm
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA
Marketing Authorization Holder
Sandoz Canada Inc.
145 Jules-Léger
Boucherville
J4B 7K8
Quebec
CANADA

For more information

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