PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 4, 2018 Initiated: February 26, 2018 #D-0608-2018

Product Description

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.

Details

Units Affected
52,596 bottles
Distribution
Nationwide within the USA.
Location
New Hope, MN

Frequently Asked Questions

What product was recalled?
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. Recalled by Paddock Laboratories, LLC.. Units affected: 52,596 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 4, 2018. Severity: Moderate. Recall number: D-0608-2018.