The Recall Desk

FDA (Drugs) recall action 90948

Akorn, Inc. recalled 27 products on 2023-01-25

The FDA (Drugs) publishes a recall like this one as 27 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 27 pages.

Products
27
Announced
2023-01-25
Critical
0
Units
11,003,824

Why these products were recalled

CGMP Deviations:

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.

26–27 of 27

  • ModerateFDA (Drugs)··2023-01-25

    Sodium Chloride Ophthalmic Ointment Recalled for Manufacturing Deviations

    Akorn, Inc. has voluntarily recalled 524,506 tubes of Sodium Chloride Ophthalmic Ointment, USP 5%, nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-01-25

    Eye-drop drug recall: Timolol solution due to manufacturing deviations

    Akorn is recalling over 1.3 million bottles of Timolol Maleate eye drops distributed nationwide due to manufacturing process violations. The voluntary recall addresses risks from Current Good Manufacturing Practice deviations.

    Product
    Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
    Category
    Distribution
    0 states