FDAFDA · Food and drugs·Recall number D-0976-2020
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
Published March 11, 2020 · Recall initiated: January 15, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Distributor
- U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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