FDA Recall D-0455-2023

Nanomaterials Discovery Corporation · Seattle, WA

Class I — life-threatening Ongoing 1185 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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: All Lots

Quantity: 500 bottles

Reason for recall

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

Recall record

Recall number: D-0455-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-02-14
Classified by FDA Center: 2023-03-09
FDA published: 2023-03-15
Recalling firm: Nanomaterials Discovery Corporation
Firm location: Seattle, WA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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