# FDA recall D-0915-2023

> **Tenn South Distillery LLC dba Big Machine Distillery** · Class II · drug recall initiated 2023-07-10.

## 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.

## Reason for recall

CGMP Deviation: impurities exceed allowable limits.

## Distribution

TN

## Key facts

- **Recall number:** D-0915-2023
- **Recalling firm:** Tenn South Distillery LLC dba Big Machine Distillery
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-07-10
- **Report date:** 2023-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lynnville, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0915-2023

## Citation

> AI Analytics. FDA recall D-0915-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0915-2023. Source: US FDA. Licensed CC0.

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