Padagis US LLC recalls Evamist estradiol transdermal spray due to failed content uniformity at 18 months. This may affect medication consistency for users. Contact for remedy details.
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Padagis US LLC is recalling Evamist estradiol transdermal spray because it failed content uniformity tests at 18 months. This could mean inconsistent hormone levels in the medication, which may affect treatment effectiveness.
The spray's hormone content became inconsistent over time, potentially leading to uneven hormone levels in the body. This could affect treatment effectiveness but does not cause immediate harm.
Prescription users of Evamist estradiol transdermal spray who received the recalled batch. Women with hormone replacement therapy needs are most at risk.
Check for the product name 'Evamist', 1.53 mg estradiol per spray, and the lot number SCDR with expiration 02/2024. The product is prescription-only.
Look for the lot number SCDR and expiration date 02/2024 on the Evamist spray label.
The recall indicates a potential issue with hormone consistency, but the product is still safe for use until the expiration date. Consult your doctor for advice.
Check the lot number and expiration date. If it matches the recalled batch (SCDR, exp 02/2024), contact your doctor for guidance.
The recall record does not mention a remedy, so no specific fix is provided. Contact your doctor for advice.
We’ve drafted a message you can send Padagis to request your refund or repair — edit it as you like.
Subject: Recall D-0464-2023 — Padagis Padagis Hello, I own a Padagis that is covered by recall D-0464-2023 from Padagis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
