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

    Antihistamine eye drops recalled due to manufacturing process deviations

    Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-01-25

    Proparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations

    Akorn is voluntarily recalling Proparacaine Ophthalmic Solution nationwide due to Current Good Manufacturing Practice deviations.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12
    Category
    Distribution
    0 states