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

Recall Number: D-0485-2015

Firm: Noven Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20150422

Initiation Date: 20150225

Termination Date: 20190226

Reason for Recall

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

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