Estradiol Valerate Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable medication due to FDA inspection findings of inadequate sterility assurance. The product was distributed to approximately 494 patients across 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: This is an FDA Class II recall of an injectable pharmaceutical product. Lack of sterility assurance in injectable medications represents a significant health risk, as contaminated injections can cause serious infections or injury. The Class II designation combined with the injectable route of administration and the nature of the hazard (potential microbial contamination) supports a Severe rating.
Plain-English summary
Red Mountain Compounding Pharmacy, operating as First Royal Care Co. LLC, is recalling Estradiol Valerate 5mg/mL (multi-dose vial injection) due to lack of assurance of sterility. An FDA inspection raised concerns about the manufacturer's sterility assurance processes.
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.
Patients currently using this medication should contact their healthcare provider or prescribing pharmacist to discuss continued treatment options and potential risks. The concern stems from insufficient sterility assurance during manufacturing, which could pose health risks if the product is contaminated.
The recalled product
- Product
- ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
- Category
- Drug — Injectable Pharmaceutical
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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