Recalls / Class III
Class IIID-0464-2023
Product
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
- Brand name
- Evamist
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Transdermal
- NDC
- 0574-2067
- FDA application
- NDA022014
- Affected lot / code info
- Lot# SCDR, Exp 02/2024
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.
Recalling firm
- Firm
- Padagis US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3940 Quebec Ave N, N/A, Minneapolis, Minnesota 55427-1244
Distribution
- Quantity
- 43,238 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-02-21
- FDA classified
- 2023-03-10
- Posted by FDA
- 2023-03-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0464-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.