Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 2...
FDA Recall #D-0109-2024 — Class II — October 18, 2023
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.
Recalling Firm
Integrity Bio-Chemicals LLC — Cresson, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1 55-gallon drum
Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated