FDAJuly 10, 2023drug
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 g...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviation: impurities exceed allowable limits.
What to do
FDA enforcement status: Ongoing
Brands named
tenn south distillery llc dba big machine distillerytenntenn south
UPCs
859105004525859105004532859105004549859105004517
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCGreenworks Tools Recalls 24V and 48V Kobalt Yard Power Tools with USB-C Batteries Due to Risk of Serious Injury from Fire Hazard2026-07-09
- CPSCFlaunt Recalls Magsafe Battery Chargers Due to Risk of Serious Injury or Death from Fire and Burn Hazards2026-07-09
- CPSCJunpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries; Sold on Amazon by JSNJ_Tech Store2026-07-02
- CPSCRowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards2026-07-02
- CPSCRaychy Children's Light Sneakers Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Consumer Products with Coin Batteries; Imported by Carina and Rambo2026-06-25
- CPSCArizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by 7111495 Canada2026-06-18
- CPSCLiKee Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Standard for Toys; Sold on Amazon by ChilanTech2026-06-11
- CPSCResistance Bands Recalled Due to Serious Injury from Impact Hazard; Imported by HomeProGym2026-05-21
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