Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Akorn | Location not on file | Makes it, tests it, packages it, labels it and sterilizes it | Not inspected on record |
| Akorn | Location not on file | Makes it, tests it and sterilizes it | Not inspected on record |
| Ophtapharm AG | Hettlingen, Switzerland | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 28, 2020 · 5 inspections |
| Akorn | Location not on file | Packages it and labels it | Not inspected on record |
Recalls
- Oct 13, 2022 · Class II · Akorn, Inc.
CGMP Deviations:
Lots: Lot: 11B26A, EXP 1/31/2023; 1H02A, EXP 7/31/2023;
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ofloxacin: every company that makes it
- Form
- solution/ drops
- Strength
- 3 mg per 1 mL
- Approval
- ANDA ANDA076407
- On the market since
- Mar 27, 2015
- Package NDCs
13985-602-0513985-602-10- Official label
- DailyMed (National Library of Medicine), updated Feb 3, 2022
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?