Why it was recalled
CGMP Deviation: impurities exceed allowable limits.
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.
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0915-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 10, 2023
- FDA report date
- Jul 19, 2023
- Quantity
- 540 gallons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tenn South Distillery LLC dba Big Machine Distillery
Original FDA data
Every field from FDA enforcement report D-0915-2023, exactly as published.
Show all FDA fields
- City
- Lynnville
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 92634
- Address
- 1800 Abernathy Rd
- Code information
- All lots remaining within expiry.
- Postal code
- 38472-5006
- Report date
- Jul 19, 2023
- Product type
- Drugs
- Recall number
- D-0915-2023
- Classification
- Class II
- Recalling firm
- Tenn South Distillery LLC dba Big Machine Distillery
- Product quantity
- 540 gallons
- Reason for recall
- CGMP Deviation: impurities exceed allowable limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- TN
- Recall initiation date
- Jul 10, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 12, 2023