FDA Drug recall D-0364-2025
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05
- FDA Drug
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05 by Direct Rx, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0364-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-31 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | AL, CA, FL, GA, ID |
Product
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
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
Identifiers
| 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0364-2025%22
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