Class II
Terminated
Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8
This recall has been terminated (originally issued April 22, 2015).
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- February 25, 2015
- Posted
- April 22, 2015
- Recall Number
- D-0485-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 720 transdermal patches
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Distribution
Nationwide
Lot / Code Info
Lot # 76476; Exp 07/16
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