Drug recall D-0700-2021
Product
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.
Reason for recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Lots and codes
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.
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Quantity
- 350,985 cartons
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 9, 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