Recalls / Class II
Class IID-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
- Brand name
- Minivelle
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Transdermal
- NDCs
- 68968-6610, 68968-6625, 68968-6637, 68968-6650, 68968-6675
- FDA application
- NDA203752
- Affected lot / code info
- Lot #: 88584 Exp. 03/2022
Why it was recalled
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.
Recalling firm
- Firm
- Noven Pharmaceuticals Inc
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 Sw 144th St, N/A, Miami, Florida 33186-6109
Distribution
- Quantity
- 12060 cartons
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-04-16
- FDA classified
- 2021-04-20
- Posted by FDA
- 2021-04-28
- Terminated
- 2024-10-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0336-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.