Drug recall D-0336-2021
Product
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8
Reason for recall
Defective Delivery System: Out of specification for release rate testing and 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 #: 88584 Exp. 03/2022
Recall details
- Recalling firm
- Noven Pharmaceuticals Inc, Miami, FL
- Quantity
- 12060 cartons
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 16, 2021
- Terminated
- October 11, 2024
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