FDA recall D-0923-2017

Product

Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8

Reason for recall

Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.

Distribution

Nationwide within US

Key facts

Status

Terminated

Initiation date

2017-04-27

Report date

2017-07-05

Termination date

2019-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0923-2017