Mitomycin Injection Solution Recalled Due to Lack of Sterility Assurance
Mitomycin Injection Solution manufactured by Northern VA Compounders PLLC is being recalled because sterility cannot be assured. Patients receiving this product should contact their healthcare provider.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a sterile injectable drug where sterility cannot be assured, representing a risk-of-harm scenario. No illnesses or injuries have been reported, placing this in the High category per the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Mitomycin Injection Solution, 4 mg/mL packaged in 10 mL multiple-dose vials, manufactured by Northern VA Compounders PLLC. The affected lots are Lot 12062022@7 (expiration 1/20/2023) and Lot 12072022@32 (expiration 1/22/2023).
The manufacturer has determined that sterility cannot be assured for these vials. As an injectable drug, sterility is a critical safety requirement.
The product was distributed nationwide in the United States. If you received this product, contact your healthcare provider or pharmacist immediately. Do not use the recalled vials.
The recalled product
- Product
- Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
- Manufacturer
- Northern VA Compounders PLLC
- Category
- Drug — Chemotherapy
- Affected units
- 2
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 (4)
- Lot#: 12062022@7
- Exp 1/20/2023
- 12072022@32
- Exp 1/22/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Northern VA Compounders PLLC 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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