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.
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
Lot numbers, UPCs & expiration codes
Lot #: 88584 Exp. 03/2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0336-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 16, 2021
- FDA report date
- Apr 28, 2021
- Quantity
- 12060 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0336-2021, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 87741
- Address
- 11960 Sw 144th St
- Code information
- Lot #: 88584 Exp. 03/2022
- Postal code
- 33186-6109
- Report date
- Apr 28, 2021
- Product type
- Drugs
- Recall number
- D-0336-2021
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals Inc
- Product quantity
- 12060 cartons
- Termination date
- Oct 11, 2024
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Apr 16, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 20, 2021