Reported Mar 22, 2023 · Ongoing
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx…
Padagis US LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Padagis US LLC · 3940 Quebec Ave N · Minneapolis, MN · 55427-1244
Is this the product you have?
- 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 forPerrigo, Allegan, Minnapolis, MN 55427
- NDC0574-2067-27
- Lot codes and dates
- Lot# SCDR, Exp 02/2024
- Amount recalled
- 43,238 cartons
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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