Teva-Varenicline  (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-75369

Last updated:

Summary

  • Product: Teva-Varenicline (combo)

Reason

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

Depth of distribution

Retailers, Wholesalers

Affected products

Teva-Varenicline

DIN, NPN, DIN-HIM

DIN 02426781

Dosage form

Tablet

Strength

Varenicline (Varenicline Tartrate) 0.5mg

Varenicline (Varenicline Tartrate) 1mg

Lot or serial number

K60796

Companies

Recalling Firm
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA