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
Reason for recall: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Recall initiated: 20180907
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated