FDA-Drug2018-01-03Class II

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

Simple Diagnostics, Inc.
Hazard

Lack of Assurance of Sterility and cGMP Deviations

Sold states
Product was distributed throughout the United States
Affected count
150,250 alcohol pads
Manufactured in
11555 Heron Bay Blvd Ste 200, N/A, Coral Springs, FL, United States
Products
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05

Official notice

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

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