Health product recall

Teva-Varenicline 0.5mg (2021-04-06)

Starting date:
April 6, 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-75365

Last updated:
2021-04-12

Summary

  • Product:
    Teva-Varenicline

Reason

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

Depth of distribution

Retailers, Wholesalers

Affected products

Teva-Varenicline 

DIN, NPN, DIN-HIM

DIN 02426226

Dosage form

Tablet

Strength

Varenicline (Varenicline Tartrate) 0.5mg

Lot or serial number

K60795

Companies

Recalling Firm

Teva Canada Ltd.

30 Novopharm Court

Toronto

M1B 2K9

Ontario

CANADA

Marketing Authorization Holder

Teva - Novopharm Ltd.

30 Novopharm Court,

Toronto

M1B 2K9

Ontario

CANADA