Recalls / Class III
Class IIID-0923-2017
Product
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
- Brand name
- Minivelle
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Transdermal
- NDCs
- 68968-6610, 68968-6625, 68968-6637, 68968-6650, 68968-6675
- FDA application
- NDA203752
- Affected lot / code info
- Lot #:: 78618, Exp. 05/2017
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.
Recalling firm
- Firm
- Noven Pharmaceuticals, Inc.
- Manufacturer
- Noven Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11960 SW 144th St, N/A, Miami, Florida 33186-6109
Distribution
- Quantity
- 14434 cartons
- Distribution pattern
- Nationwide within US
Timeline
- Recall initiated
- 2017-04-27
- FDA classified
- 2017-06-23
- Posted by FDA
- 2017-07-05
- Terminated
- 2019-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0923-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.