Drug product
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
D-0923-2017
Product summary
- Event
- Event 77466
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14434 cartons
- Official record key
drug-enforcement:D-0923-2017
Official wording
Reason: Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Code information: Lot #:: 78618, Exp. 05/2017
Distribution pattern: Nationwide within US
Derived failure modes
-
Potency or specification failure
Out of specification