FDAFDA · Food and drugs·Recall number D-0337-2021
Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-3437-8
Published April 28, 2021 · Recall initiated: April 16, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ESTRADIOL
- Manufacturer
- Noven Pharmaceuticals Inc
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 88321 Exp. 02/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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