February 2018 FDA Recall Evamist by Paddock Laboratories, Llc.
D-0608-2018 - Defective Delivery System

This Class II drug recall was voluntarily initiated by Paddock Laboratories, Llc. on February 26, 2018 for the product Evamist. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0608-2018

Reason for Recall
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.
Initiated
02-26-2018
Reported
04-04-2018
Quantity
52,596 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79334
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Paddock Laboratories, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-16-2020
Product Description About Product Description
Full technical description of the product.
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

0574-2067-27 Evamist
0574-2067-00 Evamist