D-1208-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 3, 2018
- Initiation Date
- September 7, 2018
- Termination Date
- September 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149631 boxes of 8 patches and 15809 boxes of 2 patches
Product Description
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8
Reason for Recall
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Distribution Pattern
Nationwide
Code Information
a) 82292 Exp. 02/2019; b) 82139 Exp. 10/2018; 82292 Exp. 02/2019; and 82598 Exp. 04/2019