Skip to content
Recall Observatory FDA recall evidence

Drug product

Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25

D-0136-2023

October 13, 2022

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 90948
Status
Ongoing
Classification
Class II
Quantity
1,584 bottles
Official record key
drug-enforcement:D-0136-2023

Official wording

Reason: CGMP Deviations:

Code information: Lot: Lot 1E22A, EXP 10/31/2022

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations