NDC 80425-0379

Moxifloxacin 5 mg per 1 mL solution/ drops

On the label: Advanced Rx Pharmacy of Tennessee, LLC. It's repackaged: Advanced Rx Pharmacy of Tennessee, LLC rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-422.

Where the pills inside were made

Repackaging site

• Advanced Rx Pharmacy of Tennessee, LLC, Nashville, TN, 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

Mar 21, 2024

Package NDCs

80425-0379-1

Official label

DailyMed (National Library of Medicine), updated Mar 21, 2024

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