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Recall Observatory FDA recall evidence

Drug product

Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

D-0144-2023

October 13, 2022

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 90948
Status
Ongoing
Classification
Class II
Quantity
2,563 bottles
Official record key
drug-enforcement:D-0144-2023

Official wording

Reason: CGMP Deviations:

Code information: Lot, Expiry: Lots 1E28A, exp 4/30/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations