Why it was recalled
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Product description
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
Lot numbers, UPCs & expiration codes
Lot #:: 78618, Exp. 05/2017
Where it was sold
Nationwide within US
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-0923-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 27, 2017
- FDA report date
- Jul 5, 2017
- Quantity
- 14434 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Noven Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0923-2017, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 77466
- Address
- 11960 SW 144th St
- Code information
- Lot #:: 78618, Exp. 05/2017
- Postal code
- 33186-6109
- Report date
- Jul 5, 2017
- Product type
- Drugs
- Recall number
- D-0923-2017
- Classification
- Class III
- Recalling firm
- Noven Pharmaceuticals, Inc.
- Product quantity
- 14434 cartons
- Termination date
- Mar 11, 2019
- Reason for recall
- Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8
- Distribution pattern
- Nationwide within US
- Recall initiation date
- Apr 27, 2017
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2017