Why it was recalled
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Product description
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
Lot numbers, UPCs & expiration codes
Lots: 82199 Exp. 12/2018; 83025 Exp. 05/2019
Where it was sold
Nationwide
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-1209-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 7, 2018
- FDA report date
- Oct 3, 2018
- Quantity
- 26217 boxes of 8 patches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1209-2018, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 80997
- Address
- 11960 SW 144th St
- Code information
- Lots: 82199 Exp. 12/2018; 83025 Exp. 05/2019
- Postal code
- 33186-6109
- Report date
- Oct 3, 2018
- Product type
- Drugs
- Recall number
- D-1209-2018
- Classification
- Class II
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 26217 boxes of 8 patches
- Termination date
- Sep 9, 2020
- Reason for recall
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 25, 2018