Hand Sanitizer Recalled for Chemical Contamination Above Specifications
Integrity Biochem 70% alcohol hand sanitizer recalled due to acetal and acetaldehyde contamination above USP limits. The 55-gallon drums distributed in Oklahoma may not meet safety standards.
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 with no reported illnesses or injuries, involving chemical impurities above USP specifications in a topical product. Per the severity rubric, this constitutes a risk-of-harm scenario without documented harm, scoring as High (3).
Plain-English summary
Integrity Bio-Chemicals LLC is recalling Integrity Biochem HSC70-LV, a 70% alcohol antiseptic hand sanitizer with lavender scent, supplied in 55-gallon drums. The recall was initiated following a Current Good Manufacturing Practice (CGMP) deviation: third-party testing identified acetal and acetaldehyde at levels exceeding those specified in United States Pharmacopeia (USP) standards.
The affected lot is number 2133608, manufactured November 23, 2021 (NDC 77512-047-03). The product was distributed to a wholesaler in Oklahoma, with the possibility of further downstream distribution. Hand sanitizers with chemical impurities above specified limits may not be safe or effective for topical use.
The recalled product
- Product
- Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
- Manufacturer
- Integrity Bio-Chemicals LLC
- Category
- Drug — Topical Hand Sanitizer
- Hazard
- acetal-above-spec
- acetaldehyde-above-spec
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 #: 2133608
- No exp Date. Manufacturing Date: 11/23/21
Distribution
Distributed in 1 state:
- OK
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