Testosterone Cypionate Injectable Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling testosterone cypionate 200mg/ml in sesame oil due to FDA concerns about lack of sterility assurance. The product was distributed to approximately 494 patients across seven states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable product with lack of sterility assurance—a high-risk contamination hazard. No illnesses or injuries are reported in the source text, but the hazard (potential bacterial or fungal infection from a non-sterile injectable) is inherently serious and applies to an identifiable patient population, meeting the threshold for High severity.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling TEST CYP 200MG/ML IN SESAME OIL MDV (multiple-dose vial), a prescription testosterone cypionate injectable product. The recall was initiated following an FDA inspection that raised concerns about the manufacturer's sterility assurance procedures.
Approximately 494 patients and consumers who received prescriptions for this product are located in Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots within their expiry date are included in the recall.
Sterile injectables that lack proper sterility assurance pose a risk of bacterial or fungal contamination, which could result in infection at the injection site or systemic infection. Patients who have received this product should consult their healthcare provider about whether they need additional monitoring or medical evaluation. Healthcare providers should consider whether patients require testing or clinical observation.
The recalled product
- Product
- TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Hazard
- sterility-assurance
- bacterial-contamination
- fungal-contamination
- infection-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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