April 2017 FDA Recall Minivelle by Noven Pharmaceuticals, Inc.
D-0923-2017 - Defective Delivery System
This Class III drug recall was voluntarily initiated by Noven Pharmaceuticals, Inc. on April 27, 2017 for the product Minivelle. 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-0923-2017
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
04-27-2017
07-05-2017
14434 cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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 within US
03-11-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Batch or Lot Expiration Information
Lot# :: 78618, Exp. 05/2017
