FDA-Drug2021-08-25Class II
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
Noven Pharmaceuticals Inc
Hazard
Failed Stability Specifications; out of specification for shear.
Sold states
Nationwide.
Affected count
223,382 boxes
Manufactured in
11960 Sw 144th St, N/A, Miami, FL, United States
Products
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0724-2021Don't want to check this manually?
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