D-1210-2018 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
- 74908 boxes of 8 patches
Product Description
Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8
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
Lots: 82599 Exp. 05/2019; 82660 Exp. 03/2019; 83396 Exp. 09/2019