The Recall Desk

FDA (Drugs) recall action 88497

Pfizer Inc. recalled 4 products on 2021-09-29

The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2021-09-29
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

The agency’s own wording, quoted from the enforcement report.

1–4 of 4

  • ModerateFDA (Drugs)··2021-09-29

    Chantix (Varenicline) Tablets Recalled for Impurity Above FDA Limits

    Pfizer is recalling Chantix (varenicline) 1 mg tablets distributed nationwide due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable interim intake limit. Affected lots have expiration dates from September 2021 to December 2023.

    Product
    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 DATE: September 2021 June 2023
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-09-29

    Pfizer recalls Chantix tablets for N-nitroso-varenicline impurity

    Pfizer is recalling certain lots of Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit.

    Product
    CHANTIX (VARENICLINE TARTRATE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-09-29

    Chantix Varenicline Tablets Recalled for Nitroso Impurity

    Pfizer is recalling Chantix (varenicline) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit, a manufacturing deviation.

    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.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-09-29

    Chantix Varenicline Tablets Recalled for N-Nitroso Impurity

    Pfizer is recalling specific lots of Chantix (varenicline) 1 mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The affected lots were distributed nationwide.

    Product
    CHANTIX (VARENICLINE TARTRATE)
    Category
    Distribution
    0 states