Drug product
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8
D-0336-2021
Product summary
- Event
- Event 87741
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12060 cartons
- Official record key
drug-enforcement:D-0336-2021
Official wording
Reason: Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Code information: Lot #: 88584 Exp. 03/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification