Hand Sanitizer Recalled for Acetal and Acetaldehyde Contamination
Integrity Biochem HSC 70-LM hand sanitizer in 55-gallon drums (Lot #2133607, manufactured 11/23/2021) is being recalled due to acetal and acetaldehyde contamination above FDA standards. Product was distributed to an Oklahoma distributor.
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: The FDA's Class II classification and the presence of chemical contaminants above USP limits in a topical hand sanitizer product indicate potential health risk. This falls under 'risk-of-harm products' per the rubric, justifying High severity in the absence of reported injury.
Plain-English summary
Integrity Bio-Chemicals LLC is recalling Integrity Biochem HSC 70-LM, a 70% alcohol hand sanitizer topical gel distributed in 55-gallon drums. The FDA initiated this recall because third-party test results detected acetal and acetaldehyde at levels exceeding United States Pharmacopeia (USP) specifications, indicating a Current Good Manufacturing Practice (CGMP) deviation.
The affected product is identified by Lot #2133607, manufactured November 23, 2021, with NDC 77512-044-03. The product was distributed to one distributor in Oklahoma, with the possibility of further downstream distribution. The manufacturer is Integrity Bio-Chemicals LLC, located at 1100 North Cresson Highway, Cresson, Texas 76035.
Customers who have received this product should discontinue use immediately and contact their supplier for instructions on returning the product or obtaining a replacement.
The recalled product
- Product
- Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03
- Manufacturer
- Integrity Bio-Chemicals LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- acetal-contamination
- acetaldehyde-contamination
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 (2)
- Lot #: 2133607
- Manufacturing Date 11/23/2021 No Exp date on label.
Distribution
Distributed in 1 state:
- OK
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