Integrity Biochem HSC 70-LM recalled over manufacturing violations

Recall date

October 18, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Integrity Bio-Chemicals LLC recalls Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) d…

Recall number

D-0109-2024

FDA classification

Class II

Brand / firm

Integrity Bio-Chemicals LLC

Sold / distributed

Distributed to one distributor in OK with possibility of further distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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