FDA Drug recall D-0976-2020
Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Fr…
- FDA Drug
- Class II
- terminated
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class II recall of Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, For Intravesicular Use, Freeze, Cytoxic Agent, Preservative Fr… by Fusion Iv Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0976-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-15 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fusion Iv Pharmaceuticals |
| Distribution | US |
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
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: 07082019+52606, Exp 4/3/2020; 07242019+52742, Exp 7/22/2020; 07242019+52745, Exp 7/22/2020; 09112019+52907, Exp 5/31/2020; 11142019+53235, Exp 11/12/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0976-2020%22
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