The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0110-2024·Announced 2023-11-29

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.

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: 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

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:

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 →

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