Health product recall

Pfizer Champix Product Recall (2021-06-08)

Starting date:
June 8, 2021
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75843

Last updated:
2021-06-15

Summary

  • Product:
    A. Champix 0.5 mg tablets

    B. Champix 0.5 / 1.0 mg tablet kit

A. Champix 0.5 mg tablets

B. Champix 0.5 / 1.0 mg tablet kit

Reason

Presence of impurity N-nitrosovarenicline above the acceptable concentration limit in affected lot.  

Depth of distribution

Retailers 

Affected products

A. Champix 0.5 mg tablets

DIN, NPN, DIN-HIM

DIN 02291177

Dosage form

Tablet

Strength

Varenicline tartrate 0.5 mg 

Lot or serial number

ED7397

Companies

Recalling Firm

Pfizer Canada ULC

17300 Trans-Canada Highway

Kirkland

H9J 2M5

Quebec

CANADA

Marketing Authorization Holder

Pfizer Canada ULC

17300 Trans-Canada Highway

Kirkland

H9J 2M5

Quebec

CANADA

B. Champix 0.5 / 1.0 mg tablet kit

DIN, NPN, DIN-HIM

DIN 02298309

Dosage form

Kit

Strength

Varenicline tartrate 0.5 mg
Varenicline tartrate 1.0 mg

Lot or serial number

00019062, 00020452, 00020451

Companies

Recalling Firm

Pfizer Canada ULC

17300 Trans-Canada Highway

Kirkland

H9J 2M5

Quebec

CANADA

Marketing Authorization Holder

Pfizer Canada ULC

17300 Trans-Canada Highway

Kirkland

H9J 2M5

Quebec

CANADA