Padagis US LLC 2023-03-22 Health moderate FDA
Health · FDA · Recall #FDA-D-0464-2023
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1… Recall
Issued March 22, 2023 · Padagis US LLC
In March 2023, Padagis US LLC recalled the Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Padagis US LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Padagis US LLC
- Category
- Health
- Recall date
- March 22, 2023
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0464-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Padagis US LLC has 7 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.