FDA recall D-0608-2018

Product

Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27

Reason for recall

Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.

Distribution

Nationwide within the USA.

Key facts

Status

Terminated

Initiation date

2018-02-26

Report date

2018-04-04

Termination date

2020-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

New Hope, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0608-2018