RecallDepth
Class III Ongoing

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

Company
Padagis Us Llc
Recall Initiated
February 21, 2023
Posted
March 22, 2023
Recall Number
D-0464-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
43,238 cartons
Firm Location
Minneapolis, MN, United States

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

Lot / Code Info

Lot# SCDR, Exp 02/2024

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