The Recall Desk

FDA (Drugs) recall action 67800

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline recalled 10 products on 2014-04-30

The FDA (Drugs) publishes a recall like this one as 10 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 10 pages.

Products
10
Announced
2014-04-30
Critical
0
Units
12,312

Why these products were recalled

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–10 of 10

  • ModerateFDA (Drugs)··2014-04-30

    Nicorette Lozenges Recalled for Thickness and Potency Failures

    GlaxoSmithKline is recalling Nicorette 2 mg lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenges Due to Quality Failures

    GlaxoSmithKline is recalling Nicorette 4 mg lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-04-30

    GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed quality specifications, including being overly thick, soft, and sub or superpotent.

    Product
    Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count…
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-04-30

    GlaxoSmithKline Recalls Nicotine Lozenges Due to Failed Specifications

    GlaxoSmithKline is recalling Nicorette and store-brand nicotine lozenges because they failed specifications for thickness, softness, and potency.

    Product
    Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC…
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-04-30

    GlaxoSmithKline Recalls Nicorette Lozenge and NicoDerm CQ Combination Pack

    GlaxoSmithKline is recalling a specific lot of Nicorette Lozenge and NicoDerm CQ combination packs because the lozenges failed quality specifications.

    Product
    Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2.
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-04-30

    GlaxoSmithKline Recalls Nicorette and Nicoderm CQ Products for Quality Failures

    GlaxoSmithKline is recalling specific lots of Nicorette and Nicoderm CQ products because the lozenges failed quality specifications, including being overly thick, soft, and having incorrect potency.

    Product
    Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2.
    Category
    Distribution
    0 states