FDA-Drug2017-07-05Class III
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Noven Pharmaceuticals, Inc.
Hazard
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Sold states
Nationwide within US
Affected count
14434 cartons
Manufactured in
11960 SW 144th St, N/A, Miami, FL, United States
Products
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, 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-0923-2017Don't want to check this manually?
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