CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC
Summary
The FDA issued a Class II for CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Pac by Direct Rx. Reason: 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.
Details
Source
Drug Recall
External ID
D-0364-2025
Action Date
2025-04-23
Status
Ongoing
Category
drug
Product Description
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Lot/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
Quantity Affected: 477 bottles.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-31
Company
Dawsonville, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 89 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Direct Rx has 30 FDA actions in our database, including 30 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Direct Rx) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Direct Rx have FDA actions?
Direct Rx has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0364-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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