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