Compounded Anabolic Steroid Product Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling a compounded anabolic steroid product due to FDA concerns about sterility assurance identified during inspection. The product was distributed to approximately 494 patients in seven states.
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: The FDA classified this recall as Class II. A compounded injectable product with sterility assurance deficiencies poses risk of serious infection if the product is not sterile, justifying the Severe classification per the rubric criterion for FDA Class II recalls.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) in Sesame Oil, an Rx-only compounded anabolic steroid product. The recall was initiated following an FDA inspection that raised concerns about the manufacturer's ability to assure the sterility of the product.
Approximately 494 patients and consumers who received prescriptions for this product are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All affected lots remain within their expiration dates at the time of recall notification.
Patients currently using this product should contact their healthcare provider or pharmacist for guidance. The FDA classified this as a Class II recall, indicating that use of this product may cause adverse health consequences or serious adverse effects.
The recalled product
- Product
- TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME 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.
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