Drug recall
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced…
FDA recall event 92634 · Class II · Tenn South Distillery LLC dba Big Machine Distillery
Key facts
| Event ID | 92634 |
|---|---|
| Recall numbers | D-0915-2023 |
| Recalling firm | Tenn South Distillery LLC dba Big Machine Distillery |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviation: impurities exceed allowable limits. |
| Initiation date | Jul 10, 2023 |
| Report date | Jul 19, 2023 |
| City | Lynnville |
| State | TN |
| Country | United States |
| FEI number | 3011048364 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: