Cyclosporine 2% MCT Oil Suspension Recalled for Sterility Assurance
Red Mountain Compounding Pharmacy is recalling Cyclosporine 2% MCT Oil Suspension due to FDA inspection findings of sterility assurance concerns. Approximately 494 patients in seven states received prescriptions for this medication.
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: This is an FDA Class II recall involving a sterile compounded pharmaceutical product with a documented sterility assurance deficiency identified during FDA inspection. While no specific hospitalizations or reported illnesses are mentioned in the source text, sterility failure in an injectable or ophthalmic preparation presents a significant risk of serious infection and meets the Class II + inspection-identified defect threshold for a Severe rating.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Cyclosporine 2% MCT Oil Suspension (Rx only) because FDA inspection raised concerns about the lack of assurance of sterility for the product.
Approximately 494 patients and consumers received prescriptions for this medication. The affected patients are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots of the product within their expiration dates are included in this recall.
Consumers who have received this medication should consult their prescribing physician or healthcare provider regarding their treatment options and whether any additional medical evaluation is necessary.
The recalled product
- Product
- CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
- Category
- Drug — Compounded Pharmaceutical
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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