Class IIReported 2025-04-23

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

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

Recall Number

D-0364-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-01-31

Reported

2025-04-23

Distribution

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

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.