RXQ Compounding Recalls Mitomycin Ophthalmic Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Mitomycin 0.04% ophthalmic solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in ophthalmic products) are categorized as Severe (Score 4), particularly when structural or significant injury risks are implied by the lack of sterility assurance.
Plain-English summary
RXQ Compounding LLC is recalling Mitomycin 0.04% (PF) OPH SOLN, 1ML per syringe (NDC: 70731-0917-01) due to a lack of assurance of sterility. The product is a prescription ophthalmic solution manufactured by RXQ Compounding LLC, located in Athens, Ohio.
The recall includes all lots within their expiration dates. The distribution pattern is listed as nationwide in the United States. The FDA has classified this recall as Class II, indicating a situation where 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.
Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- MITOMYCIN 0.04% (PF) OPH SOLN, 1ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0917-01
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Ophthalmic Solution
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 within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by RXQ Compounding LLC 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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