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

FDA recall notice · announced April 4, 2018 · Paddock Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide within the USA.
Lot/code information: Lot: MEEF Exp. 04/2020
Quantity: 52,596 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0608-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.