FDA recall D-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

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

Key facts

Status

Ongoing

Initiation date

2023-02-21

Report date

2023-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0464-2023