FDAFDA · Food and drugs·Recall number D-0809-2021
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 September 29, 2021 · Recall initiated: August 13, 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 · Press Release
Recall details
- Brand
- CHANTIX
- Manufacturer
- Pfizer Inc.
- Distributor
- Nationwide
- UPC
- 0300690469560
- Lot
- Lots , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.