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
Reported: April 28, 2021 Initiated: April 16, 2021 #D-0336-2021
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.
Details
- Recalling Firm
- Noven Pharmaceuticals Inc
- Units Affected
- 12060 cartons
- Distribution
- Nationwide within the United States
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Noven Pharmaceuticals Inc. Units affected: 12060 cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 28, 2021. Severity: Moderate. Recall number: D-0336-2021.
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