D-0485-2015 Class II Terminated
FDA drug recall D-0485-2015 was initiated by Noven Pharmaceuticals, Inc. on Feb 25, 2015 and is designated Class II. Reason for recall: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. The recall status is terminated (terminated Feb 26, 2019). Affected quantity: 720 transdermal patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 22, 2015
- Initiation Date
- Feb 25, 2015
- Termination Date
- Feb 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 720 transdermal patches
Product Description
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
Reason for Recall
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Distribution Pattern
Nationwide
Code Information
Lot # 76476; Exp 07/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0485-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026