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Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel ...

FDA Recall #D-0111-2024 — Class II — October 18, 2023

Recall #D-0111-2024 Date: October 18, 2023 Classification: Class II Status: Terminated

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.

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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