February 2015 FDA Recall Minivelle by Noven Pharmaceuticals, Inc.
D-0485-2015 - Temperature Abuse
This Class II drug recall was voluntarily initiated by Noven Pharmaceuticals, Inc. on February 25, 2015 for the product Minivelle. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0485-2015
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
02-25-2015
04-22-2015
720 transdermal patches
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Noven Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-26-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8
Batch or Lot Expiration Information
Lot# 76476; Exp 07/16
