FDA Drug recall D-0623-2024
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only…
- FDA Drug
- Class II
- ongoing
- Published 2024-08-07
On 2024-08-07 the FDA classified a Class II recall of Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only… by Fdc, 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-0623-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-23 |
| Published | 2024-08-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fdc |
| Distribution | US |
Product
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
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
| ndc | 69315-308-02 |
|---|---|
| ndc | 69315-308-05 |
| ndc | 69315-308-10 |
| code_info | Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Fdc
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra,…
FDA Drug · Class II · 2025-08-06 · Fdc - Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra…
FDA Drug · Class II · 2025-05-14 · Fdc - Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. M…
FDA Drug · Class II · 2025-03-26 · Fdc - Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra,…
FDA Drug · Class II · 2025-02-12 · Fdc - Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfie…
FDA Drug · Class II · 2025-01-15 · Fdc
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0623-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.