Medications & Supplements/Topical Products

Inopak Ltd: Antibacterial Foaming Hand Wash Recalled for Microbial Contamination

Agency Publication Date: June 13, 2018

Summary

Inopak Ltd is recalling 1,345 cases of Option Systems Antibacterial Foaming Hand Wash with .3% PCMX in 1000 mL pouches. The recall was initiated because FDA testing found the product was contaminated with high levels of bacteria (out-of-specification aerobic microbial counts). This non-sterile hand wash was distributed nationwide and manufactured in the United States.

Risk

The product is contaminated with bacteria, which can cause infections, particularly for individuals with weakened immune systems or those with broken skin where the soap is applied. High microbial counts in a hand wash intended for hygiene can lead to the spread of germs rather than their removal.

What You Should Do

Check your supply for Option Systems Antibacterial Foaming Hand Wash with .3% PCMX in 1000 mL pouches.
Verify the identifying codes on the packaging to see if your product is affected: 7302 01 039, 7302 03 039, 7302 01 040, or 7302 01 043.
Stop using the affected hand wash immediately to prevent potential exposure to microbial contamination.
Contact your healthcare provider or pharmacist for guidance if you have used this product and have concerns about skin irritation or infection.
Return any unused product to the place of purchase for a refund and contact Inopak Ltd at their Ringwood, NJ location for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

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

Affected Products

Product: Option Systems Antibacterial Foaming Hand Wash with .3% PCMX (1000 mL pouches)

Model:

D-0864-2018

Lot Numbers:

7302 01 039

7302 03 039

7302 01 040

7302 01 043

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80196

Status: Resolved

Manufacturer: Inopak Ltd

Sold By: distributors

Manufactured In: United States

Units Affected: 1345 cases

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 supply for Option Systems Antibacterial Foaming Hand Wash with .3% PCMX in 1000 mL pouches.

Verify the identifying codes on the packaging to see if your product is affected: 7302 01 039, 7302 03 039, 7302 01 040, or 7302 01 043.

Stop using the affected hand wash immediately to prevent potential exposure to microbial contamination.

Contact your healthcare provider or pharmacist for guidance if you have used this product and have concerns about skin irritation or infection.

Return any unused product to the place of purchase for a refund and contact Inopak Ltd at their Ringwood, NJ location for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.