Drug recall D-1207-2018
Product
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
Reason for recall
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Lots and codes
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
Recall details
- Recalling firm
- Noven Pharmaceuticals, Inc., Miami, FL
- Quantity
- 213714 boxes of 8 patches and 15927 boxes of 2 patches
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 7, 2018
- Terminated
- September 9, 2020
Related products
- Minivelle – drug information
- NDC 68968-6650 Minivelle · Estradiol .05 mg/d · Noven Therapeutics, LLC
- NDC 68968-6610 Minivelle · Estradiol .1 mg/d · Noven Therapeutics, LLC
- NDC 68968-6675 Minivelle · Estradiol .075 mg/d · Noven Therapeutics, LLC
- NDC 68968-6625 Minivelle · Estradiol .025 mg/d · Noven Therapeutics, LLC
- NDC 68968-6637 Minivelle · Estradiol .0375 mg/d · Noven Therapeutics, LLC