NDC 55150-245
Levofloxacin 750 mg per 150 mL injection, solution
On the label: AuroMedics Pharma LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Eugia Pharma Specialities Limited | Sangareddy, India | Makes it, tests it and packages it | Serious problems, FDA actionFeb 6, 2026 · 7 inspections, 2 with FDA action |
Recalls
- Mar 27, 2018 · Class II · AuroMedics Pharma LLC
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lots: Lot/Batch #'s: CLF160002, CLF160004, CLF160005 exp May 2018; CLF160006, CLF160007 exp June 2018; CLF170027 exp July 2019; CLF170029 exp August 2019 - Mar 27, 2018 · Class II · AuroMedics Pharma LLC
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lots: Lot/Batch #'s: CLF160008, CLF160009, CLF160010, CLF160011, exp June 2018; CLF160015, CLF160016 , CLF160017, exp August 2018; CLF170001 exp December 2018; CLF170023, CLF170024, exp May 2019; CLF170039, CLF170040, CLF170041, CLF170042, CLF170043, CLF170044, CLF170045, CLF170046, CLF170047 exp Augu… - Mar 27, 2018 · Class II · AuroMedics Pharma LLC
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Lots: Lot/Batch #'s: CLF160012, CLF160014 exp July 2018; CLF170007, CLF170008, CLF170009, CLF170010, CLF170011, CLF170012, CLF170013 exp February 2019; CLF170014, CLF170015, CLF170016 exp March 2019; CLF170017, CLF170018, CLF170019, exp April 2019; CLF170020, CLF170021, CLF170022 exp May 2019; CLF17… - Jan 12, 2018 · Class I · AuroMedics Pharma LLC
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Lots: Lot CLF160003, exp May 2018
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Levofloxacin: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 750 mg per 150 mL
- Approval
- ANDA ANDA206919
- On the market since
- Feb 10, 2016
- Package NDCs
55150-245-52- Official label
- DailyMed (National Library of Medicine), updated Jun 20, 2024
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?