NDC 72189-321
Moxifloxacin 5 mg per 1 mL solution/ drops
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-422.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Pithampur, India | Makes it and packages it | Serious problems, FDA actionJul 17, 2025 · 6 inspections, 4 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Feb 26, 2019 · Class III · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Lots: Lots: H701618, H701619, H701620, Exp March 2019; H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019; H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019; H703155, H703682, H703683, Exp July 2019; H704243, H704245, H704247, Exp September 2019; H704… - Feb 1, 2019 · Class III · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Lots: Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020 - Jul 26, 2018 · Class III · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Lots: Lot #: H800393, Exp. 01/2020
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, ophthalmic
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA202867
- On the market since
- Feb 7, 2022
- Package NDCs
72189-321-05- Official label
- DailyMed (National Library of Medicine), updated Jan 21, 2025
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