Recalls / Class II
Class IID-0608-2018
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
- Brand name
- Evamist
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Transdermal
- NDC
- 0574-2067
- FDA application
- NDA022014
- Affected lot / code info
- Lot: MEEF Exp. 04/2020
Why it was 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.
Recalling firm
- Firm
- Paddock Laboratories, LLC.
- Manufacturer
- Padagis US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3940 Quebec Ave N, New Hope, Minnesota 55427-1244
Distribution
- Quantity
- 52,596 bottles
- Distribution pattern
- Nationwide within the USA.
Timeline
- Recall initiated
- 2018-02-26
- FDA classified
- 2018-03-28
- Posted by FDA
- 2018-04-04
- Terminated
- 2020-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0608-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.