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
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Classification
Class II
Status
Ongoing
Lot
Lots EC9843, Exp 31, Mar 2023; EA6080, Exp. 31, Mar 2023.
Date
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