D-0923-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 5, 2017
- Initiation Date
- April 27, 2017
- Termination Date
- March 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14434 cartons
Product Description
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
Reason for Recall
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Distribution Pattern
Nationwide within US
Code Information
Lot #:: 78618, Exp. 05/2017