Coral Springs, FL, United States
Simple Diagnostics, Inc. recalls
1 recall recorded since 2018, most recently on 5 September 2017. 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
- 5 September 2017
- Terminated
- 19 September 2018
- Reason
- Lack of Assurance of Sterility and cGMP Deviations
- Distribution
- Product was distributed throughout the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0134-2018
- Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
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.