Evamist Spray
FDA Recall NDC 0574-2067
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Evamist (NDC 0574-2067). A significant event, classified as Class III, was initiated on Feb 21, 2023 by Padagis Us Llc. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
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.
Feb 21, 2023
Mar 22, 2023
43,238 cartons
Recall Profile & Regulatory Data
Event ID
91771
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Padagis US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Batch or Lot Expiration Information
Lot# SCDR, Exp 02/2024
Affected Packages Involved in this Recall
0574-2067-27Product
0574-2067-00Product
Class II Terminated
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Feb 26, 2018
Apr 04, 2018
52,596 bottles
Recall Profile & Regulatory Data
Event ID
79334
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Paddock Laboratories, LLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA.
Termination Date
Jul 16, 2020
Product Description
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27
Batch or Lot Expiration Information
Lot# Lot: MEEF Exp. 04/2020
Affected Packages Involved in this Recall
0574-2067-27Product
0574-2067-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
