Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile… — Class II drug recall D-0422-2022
Terminated recall by Edge Pharma, LLC, reported 2022-02-02, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0422-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edge Pharma, LLC, Colchester, VT, United States |
| Recall initiated | 2021-12-06 |
| Classified | 2022-01-24 |
| Reported by FDA | 2022-02-02 |
| Terminated | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 40 droptainers |
| Reason classes | sterility |
| NDC | 05446-0859-03 |
Product
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03
Reason for recall
Lack of Assurance of Sterility
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-0422-2022. 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.