Reported Aug 25, 2021 · Ongoing
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 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) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd
- byNoven Pharmaceuticals, Inc., Miami, Florida 33186, Dist
- byNoven Therapeutics LLC, Miami, Florida 33186
- Lot codes and dates
- Lots
88540 Exp. 03/202289118 Exp. 05/202289244 Exp. 07/202289244 (sample lot) Exp. 07/2022
- Lots
- Amount recalled
- 70,638 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Noven Pharmaceuticals Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.