Health product recall

Sandoz-Irbesartan/HCT 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-75699



Last updated:
2021-05-31

Summary

  • Product:
    1. Sandoz Irbesartan/HCT 150/12.5 mg Tablet
    2. Sandoz Irbesartan/HCT 300/12.5 mg Tablet
    3. Sandoz Irbesartan/HCT 300/25 mg Tablet

  1. Sandoz Irbesartan/HCT 150/12.5 mg Tablet

  2. Sandoz Irbesartan/HCT 300/12.5 mg Tablet

  3. Sandoz Irbesartan/HCT 300/25 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

A. Sandoz Irbesartan/HCT 150/12.5 mg Tablet

DIN, NPN, DIN-HIM

DIN 02337428

Dosage form

Tablet

Strength

Irbesartan 150 mg

Hydrochlorothiazide 12.5 mg

Lot or serial number

JF5840, JN4197, JN4971, JU3217, JV2167, JF8892, JN4191

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 Irbesartan/HCT 300/12.5 mg Tablet

DIN, NPN, DIN-HIM

DIN 02337436

Dosage form

Tablet

Strength

Irbesartan 300 mg

Hydrochlorothiazide 12.5 mg

Lot or serial number

JK7459, JK7460, JM3516, JM3517, JR7821, JU7500, JU7501, JU7502, JU7503, JY0147, JE2529, JM4631, JZ2686

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 Irbesartan/HCT 300/25 mg Tablet

DIN, NPN, DIN-HIM

DIN 02337444

Dosage form

Tablet

Strength

Irbesartan 300 mg

Hydrochlorothiazide 25 mg

Lot or serial number

JB0221, JB0222, JC4402, JC4404, JH2487, JR7112, JR7833, JU3181, JW9512, JW9513, KC1750, JE1833, JR8726

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


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