Drug recall D-0485-2015

Class II Terminated reported Apr 22, 2015

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

Reason for recall

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

Lots and codes

Lot # 76476; Exp 07/16

Recall details

Recalling firm
Noven Pharmaceuticals, Inc., Miami, FL
Quantity
720 transdermal patches
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 25, 2015
Terminated
February 26, 2019

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