Class III
Terminated
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
This recall has been terminated (originally issued July 5, 2017).
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- April 27, 2017
- Posted
- July 5, 2017
- Recall Number
- D-0923-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14434 cartons
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide within US
Lot / Code Info
Lot #:: 78618, Exp. 05/2017
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