Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by:
Recalled October 3, 2018 · FDA recall D-1208-2018 · Noven Pharmaceuticals
Hazard
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. · FDA Class II
Units
149631 boxes of 8 patches and 15809 boxes of 2 patches
Sold at
Nationwide
Description
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Product
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8
Manufacturer(s)
Noven Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →