NDC 85534-0075
ciprofloxacin 3 mg per 1 mL solution
On the label: Hawaii Repack, Inc.. It's repackaged: Hawaii Repack, Inc. rebottles it from Leading Pharma, LLC's NDC 69315-308.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| FDC Limited | Chhatrapati Sambhajinagar, India | Makes it and tests it | No problems foundFeb 12, 2023 · 5 inspections |
Recalls
- Mar 11, 2025 · Class II · FDC Limited
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
Lots: Lot: 084A067, Exp 12/31/2025 - Dec 16, 2024 · Class II · FDC Limited
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
Lots: Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025 - Jul 23, 2024 · Class II · FDC Limited
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.
Lots: Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ciprofloxacin: every company that makes it
- Form
- solution, ophthalmic
- Strength
- 3 mg per 1 mL
- Approval
- ANDA ANDA077568
- On the market since
- Nov 1, 2018
- Package NDCs
85534-0075-085534-0075-185534-0075-2- Official label
- DailyMed (National Library of Medicine), updated Jul 12, 2026
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