Drug recall D-0863-2018
Product
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.
Reason for recall
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.
Lots and codes
Lot #: 81896, Exp. 03/19; 82264 Exp. 12/18
Recall details
- Recalling firm
- Noven Pharmaceuticals, Inc., Miami, FL
- Quantity
- 70870 boxes
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 4, 2018
- Terminated
- June 4, 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