FDAFDA · Food and drugs·Recall number D-0863-2018
Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Published May 16, 2018 · Recall initiated: May 4, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MINIVELLE
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Distributor
- Nationwide in the USA.
- UPC
- 0368968665083
- Lot
- Lot #: 81896, Exp. 03/19; 82264 Exp. 12/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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