Drug recall D-1208-2018
Product
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8
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) 82292 Exp. 02/2019; b) 82139 Exp. 10/2018; 82292 Exp. 02/2019; and 82598 Exp. 04/2019
Recall details
- Recalling firm
- Noven Pharmaceuticals, Inc., Miami, FL
- Quantity
- 149631 boxes of 8 patches and 15809 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