Home / Recalls / Integrity Bio-Chemicals LLC / D-0109-2024

D-0109-2024 Class II Terminated

Recalled by Integrity Bio-Chemicals LLC — Cresson, TX

Recall Details

Product Type: Drugs
Report Date: November 29, 2023
Initiation Date: October 18, 2023
Termination Date: March 21, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 55-gallon drum

Product Description

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

Reason for Recall

CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.

Distribution Pattern

Distributed to one distributor in OK with possibility of further distribution

Code Information

Lot #: 2133607, Manufacturing Date 11/23/2021 No Exp date on label.