Mitomycin Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Shop is recalling Mitomycin 0.3 mg/mL Injectable vials because FDA inspections raised concerns about quality control and sterility assurance.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant risks (such as sterility assurance for injectables) are classified as Severe (Score 4), particularly when no explicit 'no illness' statement is made to cap the score at 3.
Plain-English summary
The Compounding Shop, Inc. is recalling Mitomycin 0.3 mg/mL Injectable, 10 mL vials. The recall was initiated following FDA inspection findings that resulted in concerns regarding quality control processes and the assurance of sterility for the product.
The affected product consists of 4 vials of 10 mL each. The recall covers all lots of this specific compounded product. Distribution was limited to Florida, California, Minnesota, and Maine.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Injectable
- 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 (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 25 recalled by THE COMPOUNDING SHOP, INC. 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 25 products in this recall →Related recalls
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