Drug product
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
D-1210-2018
Product summary
- Event
- Event 80997
- Status
- Terminated
- Classification
- Class II
- Quantity
- 74908 boxes of 8 patches
- Official record key
drug-enforcement:D-1210-2018
Official wording
Reason: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Code information: Lots: 82599 Exp. 05/2019; 82660 Exp. 03/2019; 83396 Exp. 09/2019
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification