Red Mountain Compounding Test Cypionate Sterility Assurance Recall
Red Mountain Compounding Pharmacy is recalling Test Cypionate 100MG/ML in Ethyl Oleate Oil due to FDA inspection findings of sterility assurance concerns.
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 product with documented sterility assurance concerns identified during FDA inspection. Failure of sterile drug products can pose serious risk of infection and adverse health consequences, meeting the threshold for Severe classification.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling TEST CYP 100MG/ML IN ETHYL OLEATE OIL (Rx only) due to a lack of assurance of sterility. During an FDA inspection, concerns were raised regarding the sterility assurance of this product.
The recalled product was distributed to approximately 494 patients and consumers who received prescriptions in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots currently within expiry are included in this recall.
Patients who have received this product should consult with their healthcare provider or pharmacist regarding whether they should discontinue use and discuss any alternative treatment options. Healthcare providers and patients are advised to report any adverse events related to this product to the FDA.
The recalled product
- Product
- TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- 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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