The Recall Desk
SevereFDA (Drugs)·D-0976-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Mitomycin-C Irrigation Solution Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Mitomycin-C Irrigation Solution because the FDA cannot assure the sterility of the product.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility for a cytotoxic agent, which presents a significant risk of serious injury or infection.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Mitomycin-C (PF) Irrigation Solution. The recall was initiated due to a lack of assurance of sterility for the affected product.

The affected product is an 80 mL multi-dose vial of Mitomycin-C (PF) 0.5 mg/mL, intended for intravesicular use. The product is a cytotoxic agent that is preservative-free and must be protected from light. The specific lots subject to recall are 07082019+52606, 07242019+52742, 07242019+52745, 09112019+52907, and 11142019+53235.

The product was distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic. Healthcare providers and patients should check their inventory and discontinue use of the affected lots.

The recalled product

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 71283-081
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Antineoplastic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Lot #: 07082019+52606
  • Exp 4/3/2020
  • 07242019+52742
  • Exp 7/22/2020
  • 07242019+52745
  • 09112019+52907
  • Exp 5/31/2020
  • 11142019+53235
  • Exp 11/12/2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 63 recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 63 products in this recall →

Related recalls

Same manufacturer · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

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Same hazard · sterility

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