Drug product
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
D-0485-2015
Product summary
- Event
- Event 70764
- Status
- Terminated
- Classification
- Class II
- Quantity
- 720 transdermal patches
- Official record key
drug-enforcement:D-0485-2015
Official wording
Reason: Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Code information: Lot # 76476; Exp 07/16
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.