Reported Sep 29, 2021 · Ongoing
Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY…
Pfizer Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfizer Inc. · 235 East 42nd Street · New York, NY · 10017-5703
Is this the product you have?
- 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.
- Lot codes and dates
Lots 00018777000192890001959300019682000198460001997700020295000204480002045800020480000210240002107300021074CW1565CW1566CW1567CW1568CW1569CW1570CW1571CW1572CW1573CW1574CW1575CW1578CW1579CW1581DF5277DF5278DF5279DF5280DF5281DF5282DR5086DR5092DR5093DR5094DT3885DW4148DW4152DY7987EC9841EC9842EC9847EC9848EE1011EM1069EM1070EN5694EN5695EP1717EP1718EP1719EW2012EW3854EW3865EX2102
- EX2103 EXPIRATION DATESeptember 2021 December 2023
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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