RecallHawk
Class I Recall

Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distribu

Nanomaterials Discovery Corporation

Summary

The FDA issued a Class I for Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Ster by Nanomaterials Discovery Corporation. Reason: Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits..

Details

Source

Drug Recall

External ID

D-0455-2023

Action Date

2023-03-15

Status

Ongoing

Category

drug

Product Description

Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.

Lot/Code Info: All Lots

Quantity Affected: 500 bottles

Reason for Recall

Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.

Distribution

Nationwide in the USA

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-14

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 126 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nanomaterials Discovery Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Nanomaterials Discovery Corporation have FDA actions?

This is the only FDA action we have on record for Nanomaterials Discovery Corporation in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0455-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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