Drug recall D-0810-2021
Product
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 FDA s acceptable interim acceptable intake limit
Lots and codes
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
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 13, 2021
Related products
- Chantix – drug information
- NDC 0069-0471 Chantix · · Pfizer Laboratories Div Pfizer Inc
- NDC 0069-0468 Chantix · Varenicline Tartrate .5 mg/1 · Pfizer Laboratories Div Pfizer Inc
- NDC 0069-0469 Chantix · Varenicline Tartrate 1 mg/1 · Pfizer Laboratories Div Pfizer Inc