Health product recall

Auro Pharma Losartan product recall (2021-10-12)

Starting date:
October 12, 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-76627



Last updated:
2021-10-15

Summary

  • Product:
    A. Auro-Losartan HCT 50mg/12.5mg

    B. Auro-Losartan HCT 100mg/12.5mg

    C. Auro-Losartan HCT 100mg/25mg

A. Auro-Losartan HCT 50mg/12.5mg

B. Auro-Losartan HCT 100mg/12.5mg

C. Auro-Losartan HCT 100mg/25mg

Reason

Presence of impurity (5-(4 '- ((5 - (Azidomethyl) -2-butyl-4-chloro-1H-imidazol-1-yl) methyl)-[1,1' - biphenyl] - 2-yl) - 1H-tetrazole above the acceptable concentration limit in affected lots.

Depth of distribution

Wholesalers, Retailers, Healthcare Establishments

Affected products

Auro-Losartan HCT 50mg/12.5mg

DIN, NPN, DIN-HIM

DIN 02423642

Dosage form

Tablet 

Strength

Losartan Potassium 50mg                                Hydrochlorothiazide 12.5mg

Lot or serial number

ACI5021007B, QX5019009-C, QX5019010-A, QX5019011-B, QX5019009-B

Companies

Recalling Firm

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA

Marketing Authorization Holder

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA


Auro-Losartan HCT 100mg/12.5mg

DIN, NPN, DIN-HIM

DIN 02423650

Dosage form

Tablet 

Strength

Losartan Potassium 100mg                                Hydrochlorothiazide 12.5mg

Lot or serial number

ACO1021003A, QY1018012-B, QY1018013-A, QY1018014-A, QY1018015-A, QY1019009-D, QY1018010-A, QY1018011-A, QY1018012-A, QY1019009-A

Companies

Recalling Firm

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA

Marketing Authorization Holder

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA


Auro-Losartan HCT 100mg/25mg

DIN, NPN, DIN-HIM

DIN 02423669

Dosage form

Tablet 

Strength

Losartan Potassium 100mg                                Hydrochlorothiazide 25mg

Lot or serial number

ACI1021007A, QX1019011-A, QX1019010-B, QX1019008-A, QX1019009-B, QX1019007-A

Companies

Recalling Firm

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA

Marketing Authorization Holder

Auro Pharma Inc.

3700 Steeles Ave. W

Woodbridge

L4L 8K8

Ontario

CANADA


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