RecallHawk
Class I Recall

Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC

Adam's Polishes LLC

Summary

The FDA issued a Class I for Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, package by Adam's Polishes LLC. Reason: Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol..

Details

Source

Drug Recall

External ID

D-0066-2023

Action Date

2022-11-23

Status

Ongoing

Category

drug

Product Description

Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.

Lot/Code Info: Lot: 133475

Quantity Affected: 3,441 gallons total

Reason for Recall

Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.

Distribution

Nationwide in the USA

Type: Voluntary: Firm initiated

Recall Initiated: 2022-11-05

Company

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 23 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Adam's Polishes LLC has 2 FDA actions in our database, including 2 recalls.

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 (Adam's Polishes LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Adam's Polishes LLC have FDA actions?

Adam's Polishes LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0066-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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