TEST CYP 25MG/ML Injectable Lacks Assurance of Sterility
Red Mountain Compounding Pharmacy is recalling TEST CYP 25MG/ML in Ethyl Oleate because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received prescriptions for this drug.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a sterility defect in an injectable drug. The source text does not report any illnesses or injuries, making the hazard theoretical rather than realized. Per the rubric, lack of reported illness with a risk-of-harm product scores 3 (High).
Plain-English summary
Red Mountain Compounding Pharmacy (First Royal Care Co. LLC) is recalling TEST CYP 25MG/ML in Ethyl Oleate, a prescription injectable medication. The recall was initiated due to lack of assurance of sterility, following an FDA inspection that raised concerns about the product's sterility control.
Approximately 494 patients and consumers who received prescriptions for this product are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots within expiry are affected by this recall.
Patients taking this medication should contact their healthcare provider or pharmacist for guidance. Do not use remaining doses without consulting a medical professional.
The recalled product
- Product
- TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Injectable Compounded
- Hazard
- sterility-assurance
- injectable-contamination
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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