FDAClass IIJanuary 3, 2018

Alcohol Prep Pads recall: Sterility Concern

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

Why was Alcohol Prep Pads recalled?

Lack of Assurance of Sterility and cGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Simple Diagnostics, Inc.
Quantity
150,250 alcohol pads
Distribution
Product was distributed throughout the United States
Recall date
January 3, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls