Mitomycin-C — Class II drug recall D-0976-2020
Terminated recall by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, reported 2020-03-11, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0976-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical, Los Angeles, CA, United States |
| Recall initiated | 2020-01-15 |
| Classified | 2020-03-05 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2023-12-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, DO |
| Reason classes | sterility |
| NDC | 71283-0812-08 |
| Expiration dates | 2020-04-03, 2020-05-31, 2020-07-22, 2020-11-12 |
Product
Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Free, Protect From Light, 80 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0812-8
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-0976-2020. 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.