Home / Recalls / Integrity Bio-Chemicals LLC / D-0111-2024

D-0111-2024 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-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

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 #: 2134106, No Exp date, Manufacturing Date: 11/23/21