Drug product
Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8
D-1207-2018
Product summary
- Event
- Event 80997
- Status
- Terminated
- Classification
- Class II
- Quantity
- 213714 boxes of 8 patches and 15927 boxes of 2 patches
- Official record key
drug-enforcement:D-1207-2018
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: a) 82200 Exp. 01/2019 b) 81637 Exp. 10/2018; 82200 Exp. 01/2019; 82293 Exp. 02/2019; 82600 Exp. 04/2019; 83027 Exp. 04/2019; 83173 Exp. 06/2019; 83396 Exp. 09/2019
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification