RecallHawk
Class II Recall

TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA App

Torco Race Fuels

Summary

The FDA issued a Class II for TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand by Torco Race Fuels. Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits..

Details

Source

Drug Recall

External ID

D-0786-2022

Action Date

2022-05-04

Status

Terminated

Category

drug

Product Description

TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA Approved, 76590-8347-1, 3780 mL, 3.78 Liters (1 Gallon). Torco Race Fuels 2527 W. Dallas Ave. Apache Junction, AZ, 85120

Lot/Code Info: No lot or Expiration date on Product

Quantity Affected: 127 gallons

Reason for Recall

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Distribution

Distributed in the USA

Type: Voluntary: Firm initiated

Recall Initiated: 2022-04-21

Company

Torco Race Fuels

Apache Junction, AZ

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 121 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

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 (Torco Race Fuels) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Torco Race Fuels have FDA actions?

This is the only FDA action we have on record for Torco Race Fuels in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0786-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for drug

Related Actions