RecallDepth
Class II Ongoing

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.

This recall is currently active, issued July 19, 2023. It was issued by Tenn South Distillery Llc Dba Big Machine Distillery.

Company
Tenn South Distillery Llc Dba Big Machine Distillery
Recall Initiated
July 10, 2023
Posted
July 19, 2023
Recall Number
D-0915-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
540 gallons
Firm Location
Lynnville, TN, United States
Official Source
View on FDA website ↗

Reason for Recall

CGMP Deviation: impurities exceed allowable limits.

Distribution

TN

Lot / Code Info

All lots remaining within expiry.

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