D-0701-2021 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 11, 2021
- Initiation Date
- June 9, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,6396 bottles
Product Description
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56
Reason for Recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Distribution Pattern
Nationwide
Code Information
Lots EC9843, Exp 31, Mar 2023; EA6080, Exp. 31, Mar 2023.