Noven Pharmaceuticals Inc recalls Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals,
Recalled April 28, 2021 · FDA recall D-0336-2021 · Noven Pharmaceuticals
Hazard
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. · FDA Class II
Units
12060 cartons
Sold at
Nationwide within the United States
Description
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Product
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8
Manufacturer(s)
Noven Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →