Drug recall D-0464-2023

Class III Ongoing reported Mar 22, 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.

Lots and codes

Lot# SCDR, Exp 02/2024

Recall details

Recalling firm
Padagis US LLC, Minneapolis, MN
Quantity
43,238 cartons
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
February 21, 2023

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