New Hope, MN, United States
Paddock Laboratories, LLC. recalls
1 recall recorded since 2018, most recently on 26 February 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 26 February 2018
- Terminated
- 16 July 2020
- 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.
- Distribution
- Nationwide within the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0608-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.