Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeu
Recalled July 5, 2017 · FDA recall D-0923-2017 · Noven Pharmaceuticals
Hazard
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH. · FDA Class III
Units
14434 cartons
Sold at
Nationwide within US
Description
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Product
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
Manufacturer(s)
Noven Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →