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:

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