D-0608-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 4, 2018
- Initiation Date
- February 26, 2018
- Termination Date
- July 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52,596 bottles
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.
Distribution Pattern
Nationwide within the USA.
Code Information
Lot: MEEF Exp. 04/2020