FDA-Drug2021-04-28Class II
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
Noven Pharmaceuticals Inc
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.
Sold states
Nationwide within the United States
Affected count
12060 cartons
Manufactured in
11960 Sw 144th St, N/A, Miami, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2021Don't want to check this manually?
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