FDA Drug · D-0464-2023

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

Class III · Ongoing

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.

Affected lots / codes — check yours against thisLot# SCDR, Exp 02/2024

Recalling firm: Padagis US LLC, Minneapolis, MN
Classification: Class III (unlikely to cause harm)
Status: Ongoing
Quantity: 43,238 cartons
Distribution: Nationwide in the USA
Recall initiated: February 21, 2023
Classified: March 10, 2023
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0464-2023%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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