Integrity Bio-Chemicals LLC: Drug Recall

Recall #D-0109-2024 · 10/18/2023

Class II: Risk

Recall Details

Recall Number: D-0109-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Integrity Bio-Chemicals LLC
Status: Terminated
Date Initiated: 10/18/2023
Location: Cresson, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 55-gallon drum

Reason for Recall

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

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

Distribution Pattern

Distributed to one distributor in OK with possibility of further distribution

Other Recalls by Integrity Bio-Chemicals LLC

Class II: Risk 10/18/2023

CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II: Risk 10/18/2023

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

View all recalls by Integrity Bio-Chemicals LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.