FDAFDA · Food and drugs·Recall number D-0923-2017
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Published July 5, 2017 · Recall initiated: April 27, 2017
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: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MINIVELLE
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Distributor
- Nationwide within US
- UPC
- 0368968665083
- Lot
- Lot #:: 78618, Exp. 05/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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