Cyclosporin 0.2% Oil Ophthalmic Suspension Recall Due to Sterility Assurance
Red Mountain Compounding Pharmacy is recalling Cyclosporin 0.2% Oil Ophthalmic Suspension because FDA inspection identified concerns about sterility assurance. The recalled drug was distributed to approximately 494 patients across multiple states.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a sterility assurance defect in a compounded pharmaceutical. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is precautionary. Per the rubric, a Class II recall without reported harm and a theoretical risk qualifies as Moderate (score 2).
Plain-English summary
Red Mountain Compounding Pharmacy (First Royal Care Co. LLC) is recalling all lots of Cyclosporin 0.2% Oil Ophthalmic Suspension, Rx only, due to lack of assurance of sterility. An FDA inspection raised concerns about the product's sterility assurance.
The recalled product was distributed to approximately 494 patients and consumers who received prescriptions. Distribution occurred across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots within expiration are included in this recall.
Patients who have received this medication should contact their prescribing healthcare provider or pharmacist for guidance. Healthcare providers who dispensed this product should consult FDA guidance on appropriate patient notification and management steps.
The recalled product
- Product
- CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
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
Part of a larger recall action
This product is one of 40 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy 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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