FDA-Drug2025-04-23Class II

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

Direct Rx
Hazard

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

Sold states
Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
Affected count
477 bottles.
Manufactured in
94 Worldwide Dr, Dawsonville, GA, United States
Products
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0364-2025

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