Drug product
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
D-1209-2018
Product summary
- Event
- Event 80997
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26217 boxes of 8 patches
- Official record key
drug-enforcement:D-1209-2018
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: 82199 Exp. 12/2018; 83025 Exp. 05/2019
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification