Drug recall D-0608-2018

Class II Terminated reported Apr 4, 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.

Lots and codes

Lot: MEEF Exp. 04/2020

Recall details

Recalling firm
Paddock Laboratories, LLC., New Hope, MN
Quantity
52,596 bottles
Distribution
Nationwide within the USA.
Type
Voluntary: Firm initiated
Recall initiated
February 26, 2018
Terminated
July 16, 2020

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