Sodium Selenite Injectable Solution Recalled for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling Sodium Selenite 200mcg/ml injectable solution due to FDA inspection findings regarding lack of assurance of sterility. Approximately 494 patients in seven states received prescriptions for this product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries documented in the source text. The hazard is a sterility assurance deficiency identified during inspection, making it a precautionary measure rather than a confirmed contamination event.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Sodium Selenite 200mcg/ml for Injection (Rx only) because an FDA inspection identified sterility assurance concerns.
The recalled product was distributed to approximately 494 patients and consumers who received prescriptions across Arizona, California, Florida, Minnesota, Montana, Texas, and Utah. All lots of the product currently within expiration are included in this recall.
Injectable products require strict sterility standards. The FDA's inspection raised concerns about the manufacturer's ability to ensure the sterility of this product, which is critical for injectable medications that bypass the body's natural barriers.
Patients who have received prescriptions for this product should consult their healthcare provider immediately. Healthcare providers should review patient medical records and take appropriate clinical action regarding any previous doses.
The recalled product
- Product
- SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
- Manufacturer
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-assurance
- injectable-safety
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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