FDA Recall D-0809-2021
Pfizer Inc. · New York, NY
Class II Ongoing 1735 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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.
Reason for recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Recall record
- Recall number
D-0809-2021- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2021-08-13
- Classified by FDA Center
- 2021-09-17
- FDA published
- 2021-09-29
- Recalling firm
- Pfizer Inc.
- Firm location
- New York, NY
Drug identification
- Brand name(s)
- CHANTIX
- Generic name(s)
- VARENICLINE TARTRATE
- Manufacturer(s)
- Pfizer Laboratories Div Pfizer Inc
- NDC(s)
0069-0468, 0069-0469, 0069-0471- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.