Recall
FDAHealthJanuary 31, 2025

Direct Rx — CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

⚠️ 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

Is this relevant to me?

Geography
AL, CA, FL, GA, ID
Source agency
FDA
Category
Health
Published
January 31, 2025

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

What's affected?

Product
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Lot code
11SE2402

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 477 bottles..

View original FDA notice →

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