Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Onl
Summary
The FDA issued a Class III for Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl o by Padagis US LLC. Reason: Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18.
Details
Source
Drug Recall
External ID
D-0464-2023
Action Date
2023-03-22
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot# SCDR, Exp 02/2024
Quantity Affected: 43,238 cartons
Reason for Recall
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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-21
Company
Minneapolis, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Padagis US LLC has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Padagis US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Padagis US LLC have FDA actions?
Padagis US LLC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0464-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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