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

April 27, 2017

Class III

Product summary

Firm: Noven Pharmaceuticals, Inc.
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
reason.potency_specification_failure · v1.0.0

Out of specification