FDAFDA · Food and drugs·Recall number D-0556-2021
Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017
Published June 2, 2021 · Recall initiated: March 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CHANTIX
- Manufacturer
- Cardinal Health Inc.
- Distributor
- FL, GA, SC
- UPC
- 0300690469560
- Lot
- EC5911
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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