Reported Oct 3, 2018 · Terminated
Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven…
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?
- Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd
- byNoven Pharmaceuticals, Inc. Miami, Florida 33186 Dist
- ByNoven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8
- Lot codes and dates
- Lots
82599 Exp. 05/201982660 Exp. 03/201983396 Exp. 09/2019
- Lots
- Amount recalled
- 74908 boxes of 8 patches
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
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.
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