FDAFDA · Food and drugs·Recall number D-0724-2021
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
Published August 25, 2021 · Recall initiated: July 30, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications; out of specification for shear.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM)
- Manufacturer
- Noven Pharmaceuticals Inc
- Distributor
- Nationwide.
- Lot
- Lots: 88542 Exp. 03/2022; 88227 Exp. 12/2021; 88696 Exp. 05/2022; 89357 Exp. 08/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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