Tenn South Distillery LLC dba Big Machine Distillery: Drug Recall

Recall #D-0915-2023 · 07/10/2023

Class II: Risk

Recall Details

Recall Number: D-0915-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Tenn South Distillery LLC dba Big Machine Distillery
Status: Ongoing
Date Initiated: 07/10/2023
Location: Lynnville, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 540 gallons

Reason for Recall

CGMP Deviation: impurities exceed allowable limits.

Product Description

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.

Distribution Pattern

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.