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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Category
- Drug — Antineoplastic
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
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.
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