Reported Apr 23, 2025 · Ongoing

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx,…

Direct Rx

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828

Is this the product you have?

  • CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN
  • Packaged and Distributed byDIRECT Rx, NDC 61919-795-05
Lot codes and dates
  • Lot 11SE2402
  • Exp Date11/30/2025 Lot 14NO2406
  • Exp Date12/31/2025 Lot 29OC2420
  • Exp Date11/30/2025 Lot 30SE2412
  • Exp Date11/30/2025
Amount recalled
477 bottles.

Where it was sold

Why it was 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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:06 PM UTC

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