FDA recall D-0786-2022

Torco Race Fuels · Class II · drug

Product

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

Reason for recall

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

Distribution

Distributed in the USA

Key facts

Status
Terminated
Initiation date
2022-04-21
Report date
2022-05-04
Termination date
2024-08-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Apache Junction, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0786-2022