Recalls / Class II
Class IID-0701-2021
Product
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56
- 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 EC9843, Exp 31, Mar 2023; EA6080, Exp. 31, Mar 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
- 69,6396 bottles
- 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-0701-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.