Health product recall

TEVA-Losartan Product Recall (2021-05-25)

Starting date:
May 25, 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-75687

Last updated:
2021-05-31

Summary

  • Product:
    1. TEVA-Losartan 50 mg Tablet
    2. TEVA-Losartan 25 mg Tablet
    3. TEVA-Losartan 100 mg Tablet
  1. TEVA-Losartan 50 mg Tablet
  2. TEVA-Losartan 25 mg Tablet
  3. TEVA-Losartan 100 mg Tablet

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

  1. TEVA-Losartan 50 mg Tablet

DIN, NPN, DIN-HIM

DIN 02357968

Dosage form

Tablet

Strength

Losartan Potassium 50 mg

Lot or serial number

1040120, 1030120, 1040419, 1050419, 1060419, 1070419, 1080918, 1090918, 1090819, 1100819, 1101018, 1110819, 1111018, 1121018, 1130819, 1180919, 1010120, 1030218, 1080419, 1120819, 1141018

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. TEVA-Losartan 25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02380838

Dosage form

Tablet

Strength

Losartan Potassium 25 mg 

Lot or serial number

0010219, 0020419, 0030419, 0031018, 0040120, 0040919, 0050620, 0050919, 0060620, 0070620, 0010120, 0020120

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. TEVA-Losartan 100 mg Tablet

DIN, NPN, DIN-HIM

DIN 02357976

Dosage form

Tablet

Strength

Losartan Potassium 100 mg 

Lot or serial number

2010219, 2010420, 2020219, 2020420, 2030420, 2040219, 2060419, 2080619, 2080918, 2091018, 2101018, 2161119, 2171119, 2030218, 2070419, 2140919, 2181119, 2191119

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