FDAFDA · Food and drugs·Recall number D-1207-2018
Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8
Published October 3, 2018 · Recall initiated: September 7, 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: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MINIVELLE
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Distributor
- Nationwide
- UPC
- 0368968665083
- Lot
- a) 82200 Exp. 01/2019 b) 81637 Exp. 10/2018; 82200 Exp. 01/2019; 82293 Exp. 02/2019; 82600 Exp. 04/2019; 83027 Exp. 04/2019; 83173 Exp. 06/2019; 83396 Exp. 09/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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