Why it was recalled
Defective Delivery System: no longer meets the specification for 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) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Lot numbers, UPCs & expiration codes
Lot #: 81391, 81638 Exp. 10/18
Where it was sold
Nationwide in the USA.
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-0862-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 4, 2018
- FDA report date
- May 16, 2018
- Quantity
- 61960 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0862-2018, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 80033
- Address
- 11960 SW 144th St
- Code information
- Lot #: 81391, 81638 Exp. 10/18
- Postal code
- 33186-6109
- Report date
- May 16, 2018
- Product type
- Drugs
- Recall number
- D-0862-2018
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 61960 boxes
- Termination date
- Jun 4, 2020
- Reason for recall
- Defective Delivery System: no longer meets the specification for 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) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- May 4, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 13, 2018