FDA recall D-0364-2025

Direct Rx · Class II · drug

Product

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-01-31
Report date
2025-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dawsonville, GA, United States

Primary source

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