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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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
Part of a larger recall action
This product is one of 40 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 40 products in this recall →Related recalls
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