Drug 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
D-0608-2018
Product summary
- Event
- Event 79334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52,596 bottles
- Official record key
drug-enforcement:D-0608-2018
Official wording
Reason: 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.
Code information: Lot: MEEF Exp. 04/2020
Distribution pattern: Nationwide within the USA.
Derived failure modes
-
Unknown
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.