Drug product
Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
D-0863-2018
Product summary
- Event
- Event 80033
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70870 boxes
- Official record key
drug-enforcement:D-0863-2018
Official wording
Reason: Defective Delivery System: no longer meets the specification for 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 #: 81896, Exp. 03/19; 82264 Exp. 12/18
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Unknown
Defective Delivery System: no longer meets the specification for 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.