CLASS II Drug recall · Reported 9 Mar 2022 · FDA Enforcement Report
Moxifloxacin Ophthalmic Solution USP 0.5%, Packaged recalled
Direct Rx is recalling Moxifloxacin Ophthalmic Solution USP 0.5%, Packaged, distributed in Florida. The recall was initiated on 17 Feb 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0637-2022
- FDA event ID
- 89642
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2022
- FDA classified
- 25 Feb 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 17 Feb 2022 | Recall initiated by company | |
| 25 Feb 2022 | Classified by FDA | +8 days |
| 9 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurities/degradation specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
Where it was distributed
Florida
Questions about this recall
Why was it recalled?
Failed impurities/degradation specifications
Which lots are affected?
Lot#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23
Where was it sold?
Florida
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Moxifloxacin recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Moxifloxacin 0.8 mg/ Preservative-Free Single-Use vials recalled | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin 4 mg/ Preservative-Free Single-Use vials recalled | Imprimis Njof | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin 5mg/ml in a Single- Dose Vial recalled by Denver Solutions | Denver Solutions | Particulate Matter | Nationwide |
| Drug | CLASS II | Moxifloxacin in Balanced Salt Solution, Solution recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin in Balanced Salt Solution 400 mcg/ (100 mcg/ syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |