Lynnville, TN, United States
Tenn South Distillery LLC dba Big Machine Distillery recalls
1 recall recorded since 2018, most recently on 10 July 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 10 July 2023
- Reason
- CGMP Deviation: impurities exceed allowable limits.
- Distribution
- TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0915-2023
- 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;
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.