The Recall Desk

FDA (Drugs) recall action 95332

AbbVie Inc. recalled 2 products on 2024-10-02

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2024-10-02
Critical
0
Units
3,236,989

Why these products were recalled

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

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.

1–2 of 2

  • HighFDA (Drugs)··2024-10-02

    FDA Recalls Refresh P.M. Eye Ointment Due to Potential Sterility Breach

    AbbVie is recalling Refresh P.M. lubricant eye ointment due to potential breaches in tube seals that may compromise product sterility. Approximately 2.4 million tubes were distributed nationwide and internationally.

    Product
    Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-10-02

    Refresh LACRI-LUBE Eye Ointment Recalled for Potential Tube Seal Breach

    Allergen is recalling specific lots of Refresh LACRI-LUBE eye ointment (763,426 tubes) due to potential breaches in the tube seal that may compromise sterility. Consumers should verify their product lot number against the recall list.

    Product
    Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
    Category
    Distribution
    0 states