FDA Recall D-0464-2023

Padagis US LLC · Minneapolis, MN

Class III Ongoing 1178 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot# SCDR, Exp 02/2024

Quantity: 43,238 cartons

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.

Recall record

Recall number: D-0464-2023
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-02-21
Classified by FDA Center: 2023-03-10
FDA published: 2023-03-22
Recalling firm: Padagis US LLC
Firm location: Minneapolis, MN

Drug identification

Brand name(s): EVAMIST
Generic name(s): ESTRADIOL
Manufacturer(s): Padagis US LLC
NDC(s): 0574-2067
Route(s): TRANSDERMAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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