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
| # | Product as published |
|---|---|
| 1 | 50 mL UPC 8 59105 00452 5 |
| 2 | 100 mL UPC 8 59105 00453 2 |
| 3 | 375 mL |
| 4 | 1/2 gallon |
| 5 | 1 gallon |
| 6 | 5 gallon |
| 7 | 55 gallon |
| 8 | Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5 |
| 9 | Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9 |
| 10 | Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7 |
| 11 | The Contributor 50 mL |
| 12 | Tony Kanaan Last Lap 100 mL |
| 13 | Tony Kanaan Last Lap 375 mL |
| 14 | Trexis Insurance 50 mL |
| 15 | Team Penske 50 mL |
| 16 | Middle 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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