Hand Sanitizer Recalled for Impurities Exceeding Allowable Limits
Big Machine Distillery Hand Sanitizer is being recalled due to manufacturing impurities exceeding allowable limits. No illnesses or injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a topical antiseptic drug with manufacturing impurities exceeding allowable limits. No illnesses or injuries have been reported, placing this in the risk-of-harm category where potential danger exists but has not yet resulted in actual harm.
Plain-English summary
Big Machine Distillery is recalling all lots of its Hand Sanitizer Non-Sterile Solution (80% alcohol antiseptic) in multiple sizes ranging from 50 mL to 55 gallons. The manufacturer, Tenn South Distillery LLC dba Big Machine Distillery, is located in Lynnville, Tennessee.
The recall is being issued because the company has identified a Current Good Manufacturing Practice (CGMP) deviation. Testing found that the hand sanitizer contains impurities that exceed the allowable limits for this type of topical antiseptic product.
The affected hand sanitizer was distributed in Tennessee. A total of 540 gallons are involved in this recall. All remaining product is within its expiration date.
Consumers who have purchased this product should stop using it immediately. Contact Big Machine Distillery or the retailer where you purchased the product for instructions on returning or safely disposing of it.
The recalled product
- Product
- 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)
- Manufacturer
- Tenn South Distillery LLC dba Big Machine Distillery
- Category
- Drug — Topical Antiseptic
- Hazard
- contamination
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry.
Distribution
Distributed in 1 state:
- TN
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