Reported Jul 19, 2023 · Ongoing

Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and…

Tenn South Distillery LLC dba Big Machine Distillery

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tenn South Distillery LLC dba Big Machine Distillery · 1800 Abernathy Rd · Lynnville, TN · 38472-5006

Is this the product you have?

16 of 16 products

Products covered by this recall
#Product as published
150 mL UPC 8 59105 00452 5
2100 mL UPC 8 59105 00453 2
3375 mL
41/2 gallon
51 gallon
65 gallon
755 gallon
8Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5
9Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9
10Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7
11The Contributor 50 mL
12Tony Kanaan Last Lap 100 mL
13Tony Kanaan Last Lap 375 mL
14Trexis Insurance 50 mL
15Team Penske 50 mL
16Middle Tennessee State University Lightning 50 mL.
Lot codes and dates
  • All lots remaining within expiry.
Amount recalled
540 gallons

Where it was sold

Why it was recalled

CGMP Deviation: impurities exceed allowable limits.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.