PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: April 23, 2025 Initiated: January 31, 2025 #D-0364-2025

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Direct Rx
Units Affected
477 bottles.
Distribution
Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
Location
Dawsonville, GA

Frequently Asked Questions

What product was recalled?
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.. Recalled by Direct Rx. Units affected: 477 bottles..
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Drug on April 23, 2025. Severity: Moderate. Recall number: D-0364-2025.