FDA (Drugs) recall action 88077
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Pfizer is recalling approximately 350,985 cartons of Chantix (varenicline tartrate) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects multiple lot numbers with expiration dates ranging from September 2021 to January 2023.
Pfizer is recalling Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects 59,232 bottles.
Pfizer is recalling Chantix (varenicline tartrate) 1 mg tablets nationwide because certain lots contain the impurity N-nitroso-varenicline above FDA's acceptable interim intake limit due to manufacturing deviations.