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Recall Observatory FDA recall evidence

Drug 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.

D-0915-2023

July 10, 2023

Class II

Product summary

Firm
Tenn South Distillery LLC dba Big Machine Distillery
Event
Event 92634
Status
Ongoing
Classification
Class II
Quantity
540 gallons
Official record key
drug-enforcement:D-0915-2023

Official wording

Reason: CGMP Deviation: impurities exceed allowable limits.

Code information: All lots remaining within expiry.

Distribution pattern: TN

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation