Recalls / Class II
Class IID-0808-2021
Product
Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.
- Affected lot / code info
- Lots 00018522, 00018523, 00018739, 00018740, 00020231, 00020232, 00020357, 00020358, 00020716, 00020813, 00021288, 00021289, 00021420, 00021687, 00021688, 00021788, 00021789, 00021790, 00021791, 00021792, 00022819, 00022851, 00023136, 00023137, 00023190, 00023448, DM0275, DM0276, DM0277, DY4470, EC5911, EC5912, ED6814, ET1600, ET1603, ET1607, ET1609, ET1611 EXPIRATION DATE: August 2021 January 2023
Why it was recalled
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-08-13
- FDA classified
- 2021-09-17
- Posted by FDA
- 2021-09-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0808-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.