TEST CYP/PROP Compounded Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling TEST CYP/PROP 160/40MG/ML MDV in ethyl oleate due to FDA inspection findings that raised concerns about sterility assurance. Approximately 494 patients in multiple states received affected prescriptions.
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 of a sterile injectable pharmaceutical product. Lack of sterility assurance in injectable medications represents a significant potential for serious adverse health consequences, including infection and sepsis, meeting the criteria for a Severe severity classification.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling TEST CYP/PROP 160/40MG/ML MDV in ethyl oleate, a prescription injectable medication. The FDA conducted an inspection that raised sterility assurance concerns regarding the product's manufacturing process and controls.
Approximately 494 patients received prescriptions for this product and are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots of the product currently within expiration date are included in this recall.
Consumers who have received this product should consult their healthcare provider or pharmacist regarding the recall and their treatment options. Patients should not discontinue use without speaking to their healthcare provider, as this is a prescription medication.
The recalled product
- Product
- TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
- Category
- Drug — Compounded Injectable
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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