FDA Drugs recall ·

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only… recall

Recall number
D-0364-2025
Date
(initiated January 31, 2025)
Company / brand
Direct Rx
94 Worldwide Dr, Dawsonville, GA, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
477 bottles.
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Why was it recalled?

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot 11SE2402, Exp Date: 11/30/2025 Lot 14NO2406, Exp Date: 12/31/2025 Lot 29OC2420, Exp Date: 11/30/2025 Lot 30SE2412, Exp Date: 11/30/2025

Distribution

Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID

States: Alabama California Florida Georgia Idaho

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0364-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.