Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmac…

Recall date

September 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1210-2018

FDA classification

Class II

Brand / firm

Noven Pharmaceuticals, Inc.

Sold / distributed

Nationwide

Why it was recalled

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8