Tenn South Distillery LLC dba Big Machine Distillery recalls Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distrib
Recalled July 19, 2023 · FDA recall D-0915-2023 · Tenn South Distillery LLC
Hazard
CGMP Deviation: impurities exceed allowable limits. · FDA Class II
Units
540 gallons
Sold at
TN
Description
CGMP Deviation: impurities exceed allowable limits.
Product
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e) 1 gallon; f) 5 gallon; g) 55 gallon; i) Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5; j) Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9; k) Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7; l) The Contributor 50 mL; m) Tony Kanaan Last Lap 100 mL; n) Tony Kanaan Last Lap 375 mL; o) Trexis Insurance 50 mL; p) Team Penske 50 mL; q) Middle Tennessee State University Lightning 50 mL.
Manufacturer(s)
Tenn South Distillery LLC dba Big Machine Distillery
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →