Class II
Terminated
Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
This recall has been terminated (originally issued May 16, 2018).
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- May 4, 2018
- Posted
- May 16, 2018
- Recall Number
- D-0862-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 61960 boxes
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Distribution
Nationwide in the USA.
Lot / Code Info
Lot #: 81391, 81638 Exp. 10/18
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