NDC 61919-795
Ciprofloxacin 3 mg per 1 mL solution
On the label: Direct Rx. It's repackaged: Direct Rx 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 |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
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 - Jan 31, 2025 · Class II · Direct Rx
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 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 - 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
- Strength
- 3 mg per 1 mL
- Approval
- ANDA ANDA077568
- On the market since
- Jul 23, 2019
- Package NDCs
61919-795-0561919-795-25- Official label
- DailyMed (National Library of Medicine), updated May 18, 2023
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