Class II
Terminated
Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8
This recall has been terminated (originally issued October 3, 2018).
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- September 7, 2018
- Posted
- October 3, 2018
- Recall Number
- D-1210-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 74908 boxes of 8 patches
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Distribution
Nationwide
Lot / Code Info
Lots: 82599 Exp. 05/2019; 82660 Exp. 03/2019; 83396 Exp. 09/2019
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