Test Cyp Injectable Drug Recalled for Sterility Assurance Defects
First Royal Care Compounding Pharmacy is recalling Test Cyp 50mg/ml in ethyl oleate oil due to FDA inspection findings that raised concerns about sterility assurance. About 494 patients in seven states received prescriptions for the affected product.
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 FDA classified this as a Class II recall. Lack of sterility assurance in an injectable drug poses a serious risk of infection or other life-threatening complications to patients, meeting the "Severe" threshold for FDA Class II recalls with significant potential for harm.
Plain-English summary
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy, is recalling Test Cyp 50mg/ml in ethyl oleate oil (a prescription testosterone compound) because an FDA inspection raised sterility assurance concerns about the product.
Approximately 494 patients or consumers received prescriptions for this product. They are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All affected lots remain within their expiration dates.
Patients should contact their healthcare provider or pharmacy if they have questions about whether they received this product or if they have experienced any adverse effects. The firm is working with the FDA regarding this recall.
The recalled product
- Product
- TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-defect
- compounding-error
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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