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.
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: 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
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Compounded Pharmaceutical
- Hazard
- sterility-assurance
- contamination-risk
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 in 7 states:
- AZ
- CA
- FL
- MN
- MT
- TX
- UT
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