FDA-Drug2018-10-03Class II
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
Noven Pharmaceuticals, Inc.
Hazard
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Sold states
Nationwide
Affected count
213714 boxes of 8 patches and 15927 boxes of 2 patches
Manufactured in
11960 SW 144th St, Miami, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1207-2018Don't want to check this manually?
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