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.
Check against the official notice below — it lists the full affected range.
Pfizer Inc. is recalling Chantix (varenicline) 1 mg tablets distributed nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The impurity resulted from manufacturing deviations. The recall affects multiple lot numbers with expiration dates ranging from September 2021 through December 2023.
Consumers should refer to the recall source for specific instructions on what to do if they possess affected medication, as the record does not specify a remedy.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Reason for recall: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Distribution: Nationwide Lot/code info: Lots 00018777, 00019289, 00019593, 00019682, 00019846, 00019977, 00020295, 00020448, 00020458, 00020480, 00021024, 00021073, 00021074, CW1565, CW1566, CW1567, CW1568, CW1569, CW1570, CW1571, CW1572, CW1573, CW1574, CW1575, CW1578, CW1579, CW1581, DF5277, DF5278, DF5279, DF5280, DF5281, DF5282, DR5086, DR5092, DR5093, DR5094, DT3885, DW4148, DW4152, DY7987, EC9841, EC9842, EC9847, EC9848, EE1011, EM1069, EM1070, EN5694, EN5695, EP1717, EP1718, EP1719, EW2012, EW3854, EW3865, EX2102, EX2103 EXPIRATION DATE: September 2021 December 2023
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.