Noven Pharmaceuticals Inc: Drug Recall
Recall #D-0336-2021 · 04/16/2021
Class II: Risk
Recall Details
- Recall Number
- D-0336-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Noven Pharmaceuticals Inc
- Status
- Terminated
- Date Initiated
- 04/16/2021
- Location
- Miami, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12060 cartons
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.
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
Distribution Pattern
Nationwide within the United States
Other Recalls by Noven Pharmaceuticals Inc
- Class II: Risk 10/31/2024
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
- Class II: Risk 03/10/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.