FDAFDA · Food and drugs·Recall number D-0464-2023
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27
Published March 22, 2023 · Recall initiated: February 21, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EVAMIST
- Manufacturer
- Padagis US LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot# SCDR, Exp 02/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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