Reported Sep 29, 2021 · Ongoing
Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by…
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, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03
- EXPIRATION DATESeptember 2021 June 2023
- Lot codes and dates
Lots 00019431000195420001954300019544000208140002081500020907000209650002142100021422000214230002213600022174000221750002217600022177000227650002276600023134000231350002374700023748DL3896DL7779DR2614DX4576DX5870DX5871DX5872DX5873DX7805DY6078DY7060DY9367DY9473DY9475DY9476DY9505EC5910EC5913EE9391EF2346EM4805EM4807EN2005ET1601ET1605
- ET1606 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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