Health product recall

Sandoz-Valsartan Product Recall (2021-05-27)

Starting date:
May 27, 2021
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-75703

Last updated: 2021-05-31

Summary

  • Product:
    1. Sandoz Valsartan 80mg Tablet
    2. Sandoz Valsartan 160mg Tablet
    3. Sandoz Valsartan 320mg Tablet
  1. Sandoz Valsartan 80mg Tablet

  2. Sandoz Valsartan 160mg Tablet

  3. Sandoz Valsartan 320mg Tablet

  4. Reason

    Presence of impurity 5-(4-(azidomethyl)-[1,1-biphenyl]-2-yl)-1H-tetrazole above the acceptable concentration limit in affected lots.

    Depth of distribution

    Retailers 

    Affected products

    A. Sandoz Valsartan 80mg Tablet

    DIN, NPN, DIN-HIM

    DIN 02356759

    Dosage form

    Tablet

    Strength

    Valsartan 80mg 

    Lot or serial number

    KT7180, KT9515

    Companies

    Recalling Firm
    Sandoz Canada Inc
    110 de Lauzon
    Boucherville
    J4B 1E6
    Quebec
    CANADA
    Marketing Authorization Holder
    Sandoz Canada Inc
    110 de Lauzon
    Boucherville
    J4B 1E6
    Quebec
    CANADA

    B. Sandoz Valsartan 160mg Tablet

    DIN, NPN, DIN-HIM

    DIN 02356767

    Dosage form

    Tablet

    Strength

    Valsartan 160mg 

    Lot or serial number

    KT9598

    Companies

    Recalling Firm
    Sandoz Canada Inc
    110 de Lauzon
    Boucherville
    J4B 1E6
    Quebec
    CANADA
    Marketing Authorization Holder
    Sandoz Canada Inc
    110 de Lauzon
    Boucherville
    J4B 1E6
    Quebec
    CANADA

    C. Sandoz Valsartan 320mg Tablet

    DIN, NPN, DIN-HIM

    DIN 02356775

    Dosage form

    Tablet

    Strength

    Valsartan 320mg

    Lot or serial number

    KT8923, KV6185

    Companies

    Recalling Firm
    Sandoz Canada Inc
    110 de Lauzon
    Boucherville
    J4B 1E6
    Quebec
    CANADA
    Marketing Authorization Holder
    Sandoz Canada Inc
    110 de Lauzon
    Boucherville
    J4B 1E6
    Quebec
    CANADA