Recalls / Class II
Class IID-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.
- Brand name
- Chantix
- Generic name
- Varenicline Tartrate
- Active ingredient
- Varenicline Tartrate
- Route
- Oral
- NDCs
- 0069-0468, 0069-0469, 0069-0471
- FDA application
- NDA021928
- Affected 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.
Why it was recalled
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 350,985 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-06-09
- FDA classified
- 2021-07-30
- Posted by FDA
- 2021-08-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0700-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.