FDA recall D-0485-2015

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-02-25

Report date

2015-04-22

Termination date

2019-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0485-2015