D-0336-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 28, 2021
- Initiation Date
- April 16, 2021
- Termination Date
- October 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12060 cartons
Product Description
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 88584 Exp. 03/2022