Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.
Check against the official notice below — it lists the full affected range.
Pfizer Inc. is recalling Chantix (varenicline) tablets distributed nationwide due to the presence of an impurity called N-nitroso-varenicline that exceeds the FDA's acceptable interim intake limit. The recall affects 350,985 cartons of the smoking cessation medication across eight lot numbers with expiration dates ranging from September 2021 through January 2023.
The affected product includes the standard Chantix starter pack containing 0.5 mg tablets for the first week and 1 mg tablets for the continuing three weeks. The source document does not specify a remedy or recommended action for consumers who may have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Reason for recall: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit Distribution: Nationwide Quantity: 350,985 cartons Lot/code info: Lots 00020231, Exp 30 Sept 2021; 00020232, Exp 30 Nov 2021; 00020357, Exp 31 Dec 2021; 00020358, Exp 31, Jan 2022; 00020716, Exp 31, Jan 2022 ; ET1600, Exp 31, Jan 2023; ET1607, Exp 31, Jan 2023 & ET1609, Exp 31, Jan 2023.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.