Mitomycin Solution Injectable — Class II drug recall D-0378-2017
Terminated recall by Wells Pharmacy Network LLC, reported 2017-01-11, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0378-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wells Pharmacy Network LLC, Ocala, FL, United States |
| Recall initiated | 2016-09-21 |
| Classified | 2017-01-04 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2021-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 41 syringes |
| Reason classes | sterility |
Product
Mitomycin Solution Injectable, Sterile 0.04%, 400 mcg/mL, 1 mL syringe, Compounded by Wells Pharmacy, Ocala, FL
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-0378-2017. 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.