Health product recall

Teva-Varenicline 1mg (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-75367



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 02426234

Dosage form

Tablet

Strength

Varenicline (Varenicline Tartrate) 1mg

Lot or serial number

K60783, K60794

Companies

Recalling Firm

Teva - Novopharm Ltd.

30 Novopharm Court,

Toronto

M1B 2K9

Ontario

CANADA

Marketing Authorization Holder

Teva - Novopharm Ltd.

30 Novopharm Court,

Toronto

M1B 2K9

Ontario

CANADA