Home / Recalls / Simple Diagnostics, Inc. / D-0134-2018

D-0134-2018 Class II Terminated

Recalled by Simple Diagnostics, Inc. — Coral Springs, FL

Recall Details

Product Type: Drugs
Report Date: January 3, 2018
Initiation Date: September 5, 2017
Termination Date: September 19, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 150,250 alcohol pads

Product Description

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 Pattern

Product was distributed throughout the United States

Code Information

Lot # SD2070420925 Exp. Date 09/2019, and Lot # SD2070421201 and Lot # SD2070420601, Exp. Date 12/2019