Medications & Supplements/Topical Products

Simple Diagnostics, Inc.: Alcohol Prep Pads Recalled for Lack of Sterility Assurance

Agency Publication Date: December 26, 2017

Summary

Simple Diagnostics, Inc. is recalling approximately 150,250 Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v) sold in boxes of 100 individual pads. The recall was issued because the pads may not be sterile due to manufacturing quality control failures and deviations from required standards. These products were distributed throughout the United States. Consumers should check their medical supplies for the affected lot numbers and contact a healthcare professional if they have concerns.

Risk

If an alcohol pad that is not sterile is used to clean the skin before an injection or medical procedure, it can introduce bacteria directly into the body. This poses a risk of causing serious skin or systemic infections.

What You Should Do

Check your medical supplies for Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v) in boxes of 100 individual pads labeled with NDC 98302-0001-05.
Verify the lot numbers and expiration dates on the packaging: look for lot SD2070420925 (Exp. 09/2019), lot SD2070421201 (Exp. 12/2019), or lot SD2070420601 (Exp. 12/2019).
If your prep pads match these lot numbers, stop using them immediately.
Contact your healthcare provider or pharmacist for guidance on safe alternatives and to discuss any health concerns.
Return any unused product to the pharmacy or place of purchase for a refund and contact Simple Diagnostics, Inc. for further instructions.
For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and product refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads

Model:

NDC 98302-0001-05

Recall #: D-0134-2018

Lot Numbers:

SD2070420925 (Exp 09/2019)

SD2070421201 (Exp 12/2019)

SD2070420601 (Exp 12/2019)

Date Ranges: September 2019, December 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78657

Status: Resolved

Manufacturer: Simple Diagnostics, Inc.

Sold By: Simple Diagnostics

Manufactured In: United States

Units Affected: 150,250 alcohol pads

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v) in boxes of 100 individual pads labeled with NDC 98302-0001-05.

Verify the lot numbers and expiration dates on the packaging: look for lot SD2070420925 (Exp. 09/2019), lot SD2070421201 (Exp. 12/2019), or lot SD2070420601 (Exp. 12/2019).

If your prep pads match these lot numbers, stop using them immediately.

Contact your healthcare provider or pharmacist for guidance on safe alternatives and to discuss any health concerns.

Return any unused product to the pharmacy or place of purchase for a refund and contact Simple Diagnostics, Inc. for further instructions.

For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).