FDA recall D-0134-2018

Simple Diagnostics, Inc. · Class II · drug

Product

Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05

Reason for recall

Lack of Assurance of Sterility and cGMP Deviations

Distribution

Product was distributed throughout the United States

Key facts

Status: Terminated
Initiation date: 2017-09-05
Report date: 2018-01-03
Termination date: 2018-09-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Coral Springs, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0134-2018