Ceftazidime Sterile Ophthalmic Solution for Injection Preservative… — Class II drug recall D-0238-2021
Terminated recall by Edge Pharma, LLC, reported 2021-01-27, distributed nationwide. Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrex
| Recall number | D-0238-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edge Pharma, LLC, Colchester, VT, United States |
| Recall initiated | 2020-03-19 |
| Classified | 2021-01-19 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 48 syringes |
| Reason classes | sterility |
Product
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This is a compounded (re-packaged) drug. Not for Resale, Hospital/Office use only. Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
Reason for recall
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
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-0238-2021. 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.