Noven Pharmaceuticals Inc recalls Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Sy
Recalled August 25, 2021 · FDA recall D-0725-2021 · Noven Pharmaceuticals
Hazard
Failed Stability Specifications; out of specification for shear. · FDA Class II
Units
70,638 boxes
Sold at
Nationwide.
Description
Failed Stability Specifications; out of specification for shear.
Product
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
Manufacturer(s)
Noven Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →