NDC 72189-076
Moxifloxacin 5 mg per 1 mL solution/ drops
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurobindo Pharma Limited's NDC 65862-840.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apitoria Pharma Private Limited | Sangareddy, India | Makes the active ingredient and tests it | Problems found, fixed voluntarilySep 27, 2024 · 6 inspections |
| 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 |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Feb 17, 2022 · Class II · Direct Rx
Failed impurities/degradation specifications
Lots: Lot#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23 - Jan 14, 2022 · Class II · Aurobindo Pharma USA Inc.
Failed Impurities/Degradation Specifications
Lots: Lot#: CMF210001, CMF210003, CMF210004, Exp 6/2023 - Dec 2, 2019 · Class III · AuroMedics Pharma LLC
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Lots: Lot #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Moxifloxacin: every company that makes it
- Form
- solution/ drops
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA206242
- On the market since
- Mar 4, 2020
- Package NDCs
72189-076-05- Official label
- DailyMed (National Library of Medicine), updated Mar 3, 2020
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