Reported Aug 25, 2021 · Ongoing
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2…
Noven Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Noven Pharmaceuticals Inc · 11960 Sw 144th St · Miami, FL · 33186-6109
Is this the product you have?
- 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
- byNoven Pharmaceuticals, Inc., Miami, Florida 33186, Dist
- byNoven Therapeutics LLC, Miami, Florida 33186
- Lot codes and dates
- Lots
88542 Exp. 03/202288227 Exp. 12/202188696 Exp. 05/202289357 Exp. 08/2022
- Lots
- Amount recalled
- 223,382 boxes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications; out of specification for shear.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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