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.
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 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
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Hazard
- sterility-deficiency
- injectable-contamination
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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