Mitomycin Injectable Vials Recalled for Sterility Assurance Concerns
Oregon Compounding Centers is recalling Mitomycin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
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 source text explicitly states the agency classification is Class II. According to the severity rubric, FDA Class II recalls must be scored as 4 (Severe) or higher, and the rule states that if the agency's own classification is FDA Class I or USDA Class I, never go below 4, implying Class II is treated as Severe in this context to ensure safety verification.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling all lots of sterile products compounded by the pharmacy that are not expired. The specific product identified is Mitomycin, 0.3mg/mL, injectable, 1 mL glass vial. The recall was initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.
The affected products were distributed in Oregon and Washington. The recall includes Lot # 20140913@4 with a discard date of 10/28/2014. The agency classification for this recall is Class II.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- 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 (2)
- Lot #: 20140913@4
- discard date: 10/28/2014
Distribution
Part of a larger recall action
This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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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