FDAFDA · Food and drugs·Recall number D-0699-2021
Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56
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 FDA s 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 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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