Moxifloxacin Ophthalmic Solution USP 0 — Class II drug recall D-0637-2022
Terminated recall by Direct Rx, reported 2022-03-09, distributed in FL. Failed impurities/degradation specifications
| Recall number | D-0637-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2022-02-17 |
| Classified | 2022-02-25 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2023-10-04 |
| Distributed | FL |
| Quantity | 44 bottles |
| Reason classes | specification failure |
| NDC | 72189-0076-05 |
| Lot numbers | 08NO2111, 18JA2218, 20DE2104 |
| Expiration dates | 2023-06-30 |
Product
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
Reason for recall
Failed impurities/degradation specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0637-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.