Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distrib
Summary
The FDA issued a Class II for Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80 by Tenn South Distillery LLC dba Big Machine Distillery. Reason: CGMP Deviation: impurities exceed allowable limits..
Details
Source
Drug Recall
External ID
D-0915-2023
Action Date
2023-07-19
Status
Ongoing
Category
drug
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/Code Info: All lots remaining within expiry.
Quantity Affected: 540 gallons
Reason for Recall
CGMP Deviation: impurities exceed allowable limits.
Distribution
TN
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-10
Company
Lynnville, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tenn South Distillery LLC dba Big Machine Distillery) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tenn South Distillery LLC dba Big Machine Distillery have FDA actions?
This is the only FDA action we have on record for Tenn South Distillery LLC dba Big Machine Distillery in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0915-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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