Health product recall

Apotex Losartan Product Recall (2019-03-08)

Starting date:
March 8, 2019
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-69278

Recalled Products

  1. APO-Losartan 25mg Tablet
  2. APO-Losartan 50mg Tablet
  3. APO-Losartan 100mg Tablet
  4. APO-Losartan / HCTZ 50/12.5 mgTablet
  5. APO-Losartan / HCTZ 100/12.5 mgTablet
  6. APO-Losartan / HCTZ 100/25 mgTablet

Reason

Affected lots manufactured with an API that may contain the impurity N-nitroso-N-methyl-4-aminobutyric acid (referred as “NMBA”) above the acceptable level.

Depth of distribution

Retailers

Affected products

A. APO-Losartan 25mg Tablet

DIN, NPN, DIN-HIM
DIN 02379058
Dosage form

Tablet

Strength

Losartan potassium 25mg

Lot or serial number

NL1453, NL1452

Companies
Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

B. APO-Losartan 50mg Tablet

DIN, NPN, DIN-HIM
DIN 02353504
Dosage form

Tablet

Strength

Losartan potassium 50mg

Lot or serial number

NK1254, NK1253

Companies
Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

C. APO-Losartan 100mg Tablet

DIN, NPN, DIN-HIM
DIN 02353512
Dosage form

Tablet

Strength

Losartan potassium 100mg

Lot or serial number

NL1461, NG2092, NH5932, NH5933, NL1460, NH5934

Companies
Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

D. APO-Losartan / HCTZ 50/12.5 mg Tablet

DIN, NPN, DIN-HIM
DIN 02371235
Dosage form

Tablet

Strength

Hydrochlorothiazide 12.5mg
Losartan potassium 50.0mg

Lot or serial number

NL1441, NZ8848, NL1445, NZ8849, NZ8860

Companies
Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

E. APO-Losartan / HCTZ 100/12.5 mg Tablet

DIN, NPN, DIN-HIM
DIN 02371243
Dosage form

Tablet

Strength

Hydrochlorothiazide 12.5mg
Losartan potassium 100mg

Lot or serial number

NG2087, NL1421, NG2086, NL1422

Companies
Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

F. APO-Losartan / HCTZ 100/25 mg Tablet

DIN, NPN, DIN-HIM
DIN 02371251
Dosage form

Tablet

Strength

Hydrochlorothiazide 25mg
Losartan potassium 100mg

Lot or serial number

NL1429, NZ8846, NZ8847, NZ8845

Companies
Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

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