Status
Ongoing
Drug Enforcement D-0915-2023
CGMP Deviation: impurities exceed allowable limits.
Classification
Class II
Report Date
July 19, 2023
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 540 gallons
- Reason for recall
- CGMP Deviation: impurities exceed allowable limits.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- TN
Location & Firm
- Recalling firm
- Tenn South Distillery LLC dba Big Machine Distillery
- Address
-
1800 Abernathy Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0915-2023
- Event ID
- 92634
- Recall initiation date
- July 10, 2023
- Center classification date
- July 12, 2023
- Code info
- All lots remaining within expiry.
- More code info
- —