Hand Sanitizer Recalled for Excess Acetal and Acetaldehyde Contamination
Integrity Biochem hand sanitizer recalled due to contamination with acetal and acetaldehyde at levels above FDA standards. The product was distributed to one Oklahoma distributor.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall with no reported illnesses or injuries. The contamination with acetal and acetaldehyde above USP limits is a risk-of-harm situation, but actual injury has not been reported, placing this in the High category per the rubric.
Plain-English summary
Integrity Bio-Chemicals LLC is recalling Integrity Biochem HSC 70-VA, a 70% alcohol hand sanitizer in vanilla-scented topical gel form supplied in 55-gallon drums. The recall was initiated because third-party testing detected the chemical contaminants acetal and acetaldehyde at levels exceeding USP (United States Pharmacopeia) specifications.
The affected product (Lot #2134106, manufactured 11/23/21, NDC 77512-052-03) was distributed to one distributor in Oklahoma, with the possibility of further distribution from that point.
Consumers and facilities that have received this product should discontinue use and contact Integrity Bio-Chemicals LLC for instructions on product return or disposal. No illnesses or injuries have been reported to date; however, the presence of these chemical contaminants above specified limits poses a potential safety risk.
The recalled product
- Product
- Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03
- Manufacturer
- Integrity Bio-Chemicals LLC
- Category
- Drug — Hand Sanitizer
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 (3)
- Lot #: 2134106
- No Exp date
- Manufacturing Date: 11/23/21
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Integrity Bio-Chemicals LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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