TEST CYP 200MG/ML injection recalled due to sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling TEST CYP 200MG/ML MDV ETHYL OLEATE due to FDA inspection findings of lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
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 with identified sterility assurance concerns in an injectable drug product. Class II recalls with identified hazards (absence of sterility assurance in a parenteral product) carry significant risk of serious adverse health consequences, meeting the Severe threshold.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling TEST CYP 200MG/ML MDV ETHYL OLEATE (testosterone cypionate, multi-dose vial, ethyl oleate vehicle) due to lack of assurance of sterility. An FDA inspection identified sterility assurance concerns with the product.
Approximately 494 patients or consumers received prescriptions for this product. Distribution was limited to the states of Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All recalled lots are within their expiration dates.
Patients who have received this product should consult with their healthcare provider or pharmacist regarding their prescriptions. Individuals with questions about the recall should contact Red Mountain Compounding Pharmacy or their prescribing healthcare provider.
The recalled product
- Product
- TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-assurance
- lack-of-sterility
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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