FDA recall D-1209-2018

Product

Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8

Reason for recall

Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-09-07

Report date

2018-10-03

Termination date

2020-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1209-2018