FDA Recalls Estradiol Valerate Injection Due to Sterility Concerns
Beacon Hill Medical Pharmacy is recalling Estradiol Valerate with Lidocaine injection because FDA inspections raised concerns about sterility assurance.
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 recall is classified as FDA Class II and involves a sterile injectable medication where sterility assurance is compromised, posing a significant risk of infection or serious injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol Valerate with Lidocaine 1% 40 mg/mL Oil Injection Solution. The product is compounded by Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions, in Southfield, Michigan. The recall covers all configurations of the sterile, prescription-only solution intended for intravenous and subcutaneous use.
The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The agency has classified this recall as Class II.
The product was distributed nationwide in the United States. Patients who have received this medication should consult their healthcare provider for guidance on next steps.
The recalled product
- Product
- ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
- Manufacturer
- Beacon Hill Medical Pharmacy, P.C.
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)
- 05022013@21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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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