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Class II: temporary or reversible health riskOngoing

Direct Rx Ciprofloxacin Ophth Solution Recall

CIPROFLOXACIN OPHTH SOLUTION, 0

Direct Rx · Dawsonville, GA

Risk level
Class II
Reported by FDA
Apr 23, 2025
Recall ID
D-0364-2025
Check your lot numberHow we source this data

Summary

Direct Rx recalled Ciprofloxacin Ophth Solution starting Jan 31, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0364-2025 on Apr 23, 2025. 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. Status: Ongoing.

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

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 numbers, UPCs & expiration codes

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

Where it was sold

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

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0364-2025
Classification
Class II
Status
Ongoing
Recall initiated
Jan 31, 2025
FDA report date
Apr 23, 2025
Quantity
477 bottles.
Recall type
Voluntary: Firm initiated
Recalling firm
Direct Rx

Original FDA data

Every field from FDA enforcement report D-0364-2025, exactly as published.

Show all FDA fields
City
Dawsonville
State
GA
Status
Ongoing
Country
United States
Event ID
96573
Address
94 Worldwide Dr
Code information
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
Postal code
30534-6828
Report date
Apr 23, 2025
Product type
Drugs
Recall number
D-0364-2025
Classification
Class II
Recalling firm
Direct Rx
Product quantity
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
Voluntary / mandated
Voluntary: Firm initiated
Product description
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Distribution pattern
Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
Recall initiation date
Jan 31, 2025
Initial firm notification
E-Mail
Center classification date
Apr 15, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0364-2025, published Apr 23, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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