FDAFDA · Food and drugs·Recall number D-0700-2021
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.
Published August 11, 2021 · Recall initiated: June 9, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CHANTIX
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide
- UPC
- 0300690469560
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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