# FDA recall D-0364-2025

> **Direct Rx** · Class II · drug recall initiated 2025-01-31.

## 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

- **Recall number:** D-0364-2025
- **Recalling firm:** Direct Rx
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-01-31
- **Report date:** 2025-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dawsonville, GA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall D-0364-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0364-2025. Source: US FDA. Licensed CC0.

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