← FDA ENFORCEMENT
D-0364-2025Class II

Direct Rx

Recalling firm
Direct Rx
Product type
Drug
Status
Ongoing
Report date
2025-04-23
Distribution
Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
Firm state
GA
Product quantity
477 bottles.
Initiated by
Voluntary: Firm initiated
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

Product description

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

Code / lot 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

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.